AQR Quality Program Manager - Technical Design Quality
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
Primary Job Function:
The function of the Manager, Quality Business Support - Technical Design Quality is to provide corporate-wide support of Abbott's Quality System and product submissions.
The candidate must possess technical proficiency and experience in the area of in vitro diagnostics design development with a working knowledge of the associated Quality System requirements and the regulatory submissions process. The candidate must have sound knowledge of product development and manufacturing processes, as well as experience working in product development and/or technical support teams.
The primary activities and responsibilities expected of this position include providing support for US IVD product submission reviews, and consultation in matters of Quality System and regulatory compliance. This role will serve as a corporate liaison and technical expert primarily to the Abbott in vitro diagnostics businesses, developing and providing a strategic framework through the technical review process implemented to deliver objective feedback and direction for product submissions.
This role is responsible for:
Developing a standard interpretation of regulatory guidance and feedback for Abbott and facilitating deployment to the divisions.
Developing, assessing, and communicating key metrics related to product submissions and facilitating implementation of best practices in design and development.
Providing senior management with assessment of submission risks and potential impacts to both regulatory submissions and sustainability of commercialized products.
The candidate must be able to:
Organize, perform detailed review, and comprehend large volumes of complex and technical data in a condensed timeframe.
Assess collective or broader impact of individual challenges identified within reviews.
Analyze and develop recommendations for actions necessary to support product submissions based on identified risks.
Effectively communicate, both verbally and in writing, the product submission review feedback to all levels of the organization.
Lead and facilitate both AQR internal and external meetings to support the review of the product submissions.
Establish, evaluate and communicate submission review process metrics based on Power BI analysis.
Develop training, seminars, workshops and/or other appropriate forums to share information and learnings acquired from the technical review process for product submissions.
Provide ongoing coaching to Abbott businesses throughout the design and development process to promote consistency and standardization.
Monitor new or changing regulatory requirements. Understand and apply industry lab standards and guidance (e.g. CLSI).
Required Qualifications:
A Bachelor's degree in technical or science related discipline is required. Advanced degree is preferred, but not required.
Preferred Qualifications:
Minimum 8 years in product design and development and/or technical support desired.
Class III or II in vitro diagnostics device background. Demonstrated understanding of domestic regulatory requirements and regulating bodies preferred.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is
$127,300.00 - $254,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations QualityDIVISION:AQR Abbott Quality and RegulatoryLOCATION:United States > Abbott Park : AP52ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 10 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyAssociate, HR Administration
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with high employer contribution
+ Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program and FreeU (*************************************************************************************************************** education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our Abbott Park, IL location within the CHR Corporate Human Resources division.
This is an entry-level administration role supporting areas of focus within GHRS with basic knowledge of HR principles. Works with supervision and guidance from experienced specialists or manager. Work assignment managed individually in alignment with managed queues and scope of work. This role is empowered to surpass expectations by collaborating, anticipating, driving to resolution, and serving with care, compassion, and confidence. May be asked to complete non-expert level tasks or work related to HR Security and Compliance scope.
**What You'll Work On**
+ Problem Solving / Issue Ownership: Responsibility for managing priorities; initiating process improvements; accountable for project outcome and deliverables
+ Analytical/Critical Thinking: Ability to assess and identify data and inputs from multiple sources, effectively assess impacts, understand interdependencies, and proactively work to solve for or mitigate challenges
+ Continuous Improvement: Listen, gather, and identify process improvement opportunities to address customer needs and drive internal process efficiencies
+ Operational Excellence: Program administrator with initiative and proactiveness to move beyond selected channels and selected scope of work with a degree of greater specialization; Works primarily with peers in own function of GHRS.
+ Adherence to Compliance: Follow program processes and protocols per established guidelines; raises red flags
**Required Qualifications**
+ Associate's degree, or 2 years of relevant work experience without a college degree
+ Relevant work experience in a shared service center or contact center
+ Languages: Proficiency in English (spoken and written). Excellent written and verbais communications skills necessary
+ Expert knowledge in HR service technology tools such as Zendesk and Workday a plus
+ Human Resources, Customer Services and Project Management experience a plus
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** (http://**********************/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at ************** , on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $22.05 - $44.15 per hour. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
Senior Director, Quality Assurance - Site Quality Leader
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the world.
Lilly is designing and building a Next-Generation Parenteral and Device Assembly/Packaging Facility in Kenosha County, Wisconsin. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up. Our new Lilly Kenosha County facility will be one of Lilly's most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
Responsibilities:
The Senior Director, Quality Assurance, serves as the Site Quality Leader and is primarily responsible for ensuring that an effective Quality Management System is in place. This includes ensuring compliance with cGMPs, policies, procedures and standards that are required to support parenteral manufacturing, device assembly, and packaging. They effectively influence the leadership on strategic direction and tactical implementation of the quality system. The individual in this role establishes the site´s quality objectives, priorities, and roadmap. The senior director leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. He/she will also provide quality support for achieving key business objectives.
The quality leader provides leadership and direction in managing product-related quality matters, assuring the independence of the quality unit, while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with global regulatory requirements. The Site Quality Leader leads and responds to regulatory agency inspections and inquiries.
Key Objectives/Deliverables:
Stay true to Lilly's values of Integrity, Excellence and Respect for People. Make sure employees are trained & understand "Red Book" ethics and compliance.
Ensure a safe and healthy work environment. Get strong participation from the Quality team to HSE program. Monitor, verify, evaluate, and drive improvement towards site goals.
Ensure staff is qualified, that the initial & continuous training/ GMP education of all personnel is carried out as needed.
Develop people capability & knowledge (technical expertise, behavioral & managerial).
Ensure communication of the quality objectives and priorities to all site personnel.
Manage resources according to quality objectives, site priorities & anticipate future business needs including headcount and finances.
Actively recruit, coach, and develop personnel within the Lilly Quality unit.
Ensure that Quality activities are performed in accordance with procedural requirements and meet planned timelines.
Provide administrative support & technical leadership to the site Quality unit.
Assures the independence of the Site Quality Unit.
Ensures the development, adequacy, and effectiveness of the site's quality management system.
Ensures systems are in place to release or reject raw materials, intermediates, packaging materials, device components, and consumables.
Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards.
Ensure all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization.
Ensure a system is in place for approving specifications, sampling instructions, test methods & batch records.
Ensure that all required quality agreements are in place & maintained.
Ensure site processes, equipment, instruments, utilities & facilities are qualified/validated and maintained for the intended use.
Ensure that there is a process at the site to perform root cause investigation for quality matters (deviations, complaints, stability failures, results out specification) and there is a system for monitoring of corrective actions. Ensure there is a process for evaluating proposed changes. Ensure the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement/enhancement initiatives are described.
Ensure development, approval and implementation of Local Quality Plan and Site Quality Manual.
Ensure that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, CAPA board) to ensure monitoring of quality indicators applied to each element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems)
Ensure that the notification/escalation process is effective, so there is appropriate resolution of quality problems. Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS. Cooperate with Qualify Person and the Global Quality leader in communication to Health Authorities (if applicable) ensuring timely reporting.
Participate in approving Annual Product Reviews.
Ensure site audit & inspection readiness. Host audits and inspections. Assure timely closure of all regulatory commitments.
Assure the adequacy & effectiveness of the site quality systems.
Participate in the Site Lead Team and lead the Quality Lead Team.
Ensure overall compliance with GMP regulations, Lilly Corporate Quality standards and regulatory requirements through review and approval of GMP documentation.
Ensure the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines.
Ensure adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor).
Basic Qualifications:
Bachelor of Science degree or equivalent in a scientific field (e.g., pharmacy, chemistry, microbiology, engineering)
Minimum of 10 years' experience in the pharmaceutical industry in parenteral operations
Minimum of 10 years' leadership experience (Ideally in Quality Assurance)
Demonstrated history of hosting regulatory inspections
Additional Skills/Preferences:
Demonstrated Technical writing ability
Demonstrated strong oral and written communication
Demonstrated ability in problem solving and critical decision-making
Demonstrated ability to coach, mentor and lead others
Demonstrated interpersonal skills with ability to influence cross-functionally and externally
Demonstrated self-motivated leadership, ensuring a fair and equitable work environment
Clear understanding of cGMPs, policies, procedures, and guidelines
Demonstrated ability to maintain a safe work environment
Additional information:
On-site presence required
Flex hours possible
Ability to travel (approximately 10%)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplySpecialty Representative/Senior Specialty Representative - Primary Care - Milwaukee, WI
Milwaukee, WI job
Career CategorySalesJob Description
Territory covers: Milwaukee, WI; Green Bay, WI; Appleton, WI
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
SPECIALTY REPRESENTATIVE/SENIOR SPECIALTY REPRESENTATIVE
Live
What you will do
Let's do this! Let's change the world!
In this vital role you will be the connection to our customers by providing clinical knowledge of our products to medical professionals and helping them navigate the complex payer environment.
We are actively searching for a Specialty Representative or Senior Specialty Representative to deliver on our commitment to serve patients. The Specialty Representative/Senior Specialty Representative acts as the primary customer contact and is responsible for implementing marketing strategy and promoting Amgen products as led by the District Manager.
Responsibilities include:
Provide current and comprehensive knowledge of Amgen's products and effectively communicate the clinical benefits to medical professionals to drive appropriate utilization of the products
Perform as a sales leader to achieve territory sales by delivering branded sales messages, conducting planned programs, scheduling and following-up with medical educational programs, and achieving or exceeding sales targets through both in-person and virtual engagement
Develop relationships to service and manage accounts which may include: customizing discussions and customer interactions based on understanding of customer needs, ensuring product access, resolving/triage reimbursement issues, and maintaining product contracts
Provide feedback on marketing strategy, analyze business effectiveness of sales activities and territory analysis, and develop territory plans with the District Manager
Partner with other colleagues to share best practices and seek to learn and grow as a Specialty Representative/Senior Specialty Representative
Demonstrate passion for our products and sustain that passion through the entire sales cycle while always building our brand and never losing sight of how we serve patients
Uphold Amgen Values: Be Science-Based; Compete Intensely and Win; Create Value for Patients, Staff, and Stockholders; Be Ethical; Trust and Respect Each Other; Ensure Quality; Work in Teams; Collaborate, Communicate, and Be Accountable
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The sales professional we seek is a motivated individual with these qualifications.
Basic Qualifications (Specialty Representative):
Bachelor's Degree OR
Associate's degree and 4 years of Sales experience OR
High school diploma/GED and 6 years of Sales experience
Basic Qualifications (Senior Specialty Representative):
Bachelor's degree and 3 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related OR
Associate degree and 6 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related OR
High school diploma / GED and 8 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related
Preferred Qualifications:
1-3 years of sales, marketing, or clinical experience (pharmaceutical or healthcare industry preferred)
Product or hospital sales experience in the areas of oncology, cardiology, inflammation, nephrology, dermatology, rheumatology, neurology, endocrinology, hepatology, gastroenterology, bone health, respiratory, hematology, or infectious diseases; and the diseases and treatments involved with these specialties
Some experience and/or pre-graduate sales or leadership training, or a demonstrated track record of success under pressure
A hunter's mindset - hungry, ambitious, and driven to exceed goals
Strong communication, storytelling, and persuasion skills with the ability to influence diverse audiences
Genuine passion for sales, relationship-building, and improving patient outcomes
Curiosity and learning agility - eager to absorb product knowledge and industry insights quickly
Resilience and adaptability - thrives in a fast-paced, competitive environment
Entrepreneurial spirit - proactive, self-motivated, and resourceful in finding creative ways to win business
Desire to build a long-term career in pharmaceutical sales, with a focus on the cardiovascular therapeutic area
Demonstrated integrity, professionalism, and accountability in all interactions
Bachelor's degree in Life Sciences or Business Administration
Adaptability with our Core Competencies: Sales Planning and Organizing; Leveraging Business, Industry, and Technical Knowledge; Communicating with Impact; Driving for Results; and Cultivating Internal and External Relationships.
Local Market knowledge
This position is open to candidates of various backgrounds and experience levels. The role level/title will be chosen based on the candidate's match to basic qualifications and level of experience required for this geography.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
The expected annual salary range for Specialty Representative in the U.S. (excluding Puerto Rico) is $89,816 to $109,775.
The expected annual salary range for Senior Specialty Representative in the U.S. (excluding Puerto Rico) is $119,415 to $145,951. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
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Auto-ApplyMedical Science Liaison/Sr. MSL - IL
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Medical Science Liaison**
**The Opportunity:**
Our Medical Science Liaison is the medical / scientific voice of expertise for Abbott Diabetes Care (ADC) products and therapeutic areas. This field-based role focuses on medical & scientific engagement with ADC stakeholders. Provides medical / scientific expert advice / guidance to key customers for ADC products & relevant therapeutic areas, including scientific exchange & professional development with key thought leaders / external experts and provides medical / scientific affairs support to the US commercial team.
The Medical Science Liaison serves to support the scientific credibility of ADC with established and emerging national & regional thoughts leaders, by supporting scientific dialogue and collaboration in areas of research, scientific publications, and medical & scientific exchange, including unsolicited requests for medical information. They also interface regularly with appropriate US commercial team members. They maintain a high level of knowledge to ensure credible dissemination of scientific information and dialogue with thoughts leaders, healthcare providers and healthcare organizations.
**What you will do:**
+ Provide scientific and medical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to ADC.
+ Ensure a strong medical and scientific presence for ADC in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to ADC.
+ Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
+ Serve as a point of contact within the medical and scientific affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant ADC products, to support their safe, effective and appropriate use.
+ Deliver credible presentations on scientific matters to health care providers, individually or in groups (meetings, clinical sessions, etc.), where requested, with the focus on Tier 1 and 2 thought leaders.
+ Participate in the selection process to identify appropriately qualified thought leaders, ADC would wish to engage in collaborative efforts - such as educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.) while ensuring a high level of scientific or educational integrity in these collaborative efforts.
+ Attend relevant scientific meetings and conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform ADC strategic priorities and initiatives. Staff the Medical Affairs area of the exhibit booth at national scientific meetings and congresses
+ Provide key thought leaders / external experts with scientific and technical support for publications of scientific or medical interest.
+ Ensure that all activities and interactions are conducted with due regard to all applicable local and national laws, regulations, guidelines, codes of conduct, company policies and accepted standards of best practice.
**Qualification Requirements:**
+ Bachelor's Degree in a health sciences field
+ Preferred Advanced degree (eg. PharmD, MD/DO, NP/DNP, PA, PhD) in a relevant scientific discipline is preferred but candidates with an undergraduate degree in a relevant discipline and demonstrated experience will be considered.
+ Licensure/Board Certification required. Clinical licensure and board certification (eg: Nurse Practitioner, Physician Associate or Pharmacist), in accordance with applicable. state and/or national regulations. Board certification must be current and relevant to the clinical scope of practice.
+ Minimum 3- 5 years in a health sciences field
**This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.
The base pay for this position is $111,300.00 - $222,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
Clinical Specialist, Peripheral - San Antonio, TX
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This is a field-based position, supporting Abbott's Vascular division. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, peripheral stents, thrombectomy catheters and atherectomy devices.
We currently have an opportunity for a Clinical Specialist, Peripheral, in San Antonio, TX. The Clinical Specialist will primarily be responsible for case planning, case support coverage, and product pull- through throughout the designated territory, and throughout the Region as needed. The Clinical Specialist will promote Vascular products through education, service and training of customers in the hospital setting. The Clinical Specialist will provide clinical education and sales support in order to assist in achieving projected sales goals, increasing sales revenues within assigned product lines, and increasing market share. This position will have a heavy focus on Vessel Closure.
What You'll Work On
Serves as the technical procedure and product expert in support of case coverage in the hospital setting.
Meet with existing and potential customers (e.g., physicians, physician office groups at hospitals) to identify their clinical needs, goals, and constraints related to patient care and to discuss and demonstrate how Vascular products can help them to achieve their goals.
Develop relationships with hospital personnel; make new contacts in hospital departments; identify key decision makers.
Serve as primary resource for clinical support in case coverage, troubleshooting and in-service education for company products.
Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to keep all customers abreast of the latest product, therapy, and technology developments and current items of interest in the industry.
Attend clinical procedures in the Cardiac Cath Lab, Interventional Radiology Lab, and Operating Room to ensure customer and patient success with Vascular products.
Respond to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical research, marketing, product development) to develop optimal solutions.
Support the broader Region as needed with case support in addition to defined territory.
Required Qualifications
Bachelor's degree or equivalent combination of education and experience
2-5+ years of related work experience
Ability to travel 50% within assigned region
Preferred Qualifications
Patient interaction experience within a lab/operating room environment
Relevant Technical Certification
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews.
The base pay for this position is
$60,000.00 - $120,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Sales ForceDIVISION:AVD VascularLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment, Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyPlanner Scheduler Maintenance
Abbott job in Waukegan, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of .
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The primary function of this position is to provide workload planning for a multiple skilled trade maintenance department (Electrical, HVAC/R, Mechanical, Plumbing, building maintenance, Rigger, and Movers) for the manufacturing, research/development laboratories, warehouse, and other facilities that make up the Lake County facilities including associated leased facilities.
The Maintenance Planner is responsible for planning of work that includes estimating of labor hours and material, parts requisition, kitting of materials, and development of a ready backlog of work for the skilled trades.
What You'll Work On
Develop complete executable job plans to include:
Safe work practices
Required job time estimates by trade and enter into CMMS(Maximo)
Required parts are available
Required tools and equipment and access will be available
Required permits and notifications are identified and requested where needed
Specific safety procedures related to required activities (LOTO, Confined Space, Line Break, Hot Work, etc.)
Authorization/Approval to perform the work.
Accountable for ensuring parts are received and kitted for planned work
Accountable for tracking ordered parts to ensure on-time completion of Job Planning
Arrange for outside contract services as required
Conduct on site evaluation of work requests
Develop cost estimates as required
Procure parts and materials for planned work
Front line customer contact for job planning and asset availability
Interface with Maintenance Operations (Group Leaders, Planners, Supervisors, and Technical Reliability Engineers) for job plan reviews as required
Responsible for planned work compliance with current standards and specifications
Responsible for the quality and accuracy of work plans
Participate in trade group meetings for assigned areas
Provide technical support for job plans
Serve as SME for job plans
Work with trades and review job histories for continuous improvement of job plans
Initiate MSSRs (add, revise, recommend)
Will be required to drive/operate autos/equipment during work shift
Accountability:
Delays and inefficiencies in completion of procedures could result in hundreds of thousands of dollars per day lost in manufacturing.
This position requires the individual to assure that all regulatory requirements are met and maintained to include FDA, GMP, OSHA, and ISO requirements.
Not meeting these regulatory requirements could result in hundreds of thousands of dollars in fines and the loss of manufacturing of Pharmaceutical, Chemical and Core Diagnostic products to market.
Flexibility is required in being able to work with all divisions operating within the Abbott Lake County plants to satisfy their needs and meet consistently conflicting schedules.
Required Qualifications
Associate's degree or the equivalent experience and/or formal post high school technical training/ certification.
This position requires at least seven years of related skilled trades work experience.
The Maintenance Planner must also have strong technical expertise so-as-to give direction to and gauge performance for the widely diverse technical services provided by this organization.
Possess a critical thinking mindset who can multi-task, prioritize, and meet deadlines in a timely manner.
Good writing and verbal skillsets for communications to management, trade groups and customers.
Must have full-time work experience with computer maintenance management systems, e-mail, and calendaring.
Must demonstrate the ability to work well with others in a commercial and/or industrial work environment.
The individual must be able to evaluate the use of various resources and make knowledgeable decisions in regard to safety and company standards and policies.
Must possess a valid driver's license.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$28.25 - $56.45/hour
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Facilities & MaintenanceDIVISION:GES Global Engineering ServicesLOCATION:United States > Waukegan : J36ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplyLegal/OEC Administrative Assistant II
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with a high employer contribution
+ Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our Abbott Park IL facility.
**What You'll Work On**
Primary Job Function:
As a Legal/OEC Administrative Assistant, you will provide administrative support to the Legal/OEC organization, including DVPs, attorneys, directors, ECOs, paralegals, and other team members.
Core Job Responsibilities:
+ This position providescomprehensivesupporttoat leastone Divisional Vice President (DVP)within the Legal/OECorganization
+ Responsibilities include alldepartmental administrative functions, includingmanagingcalendars,scheduling travel, processing expense reports, creating and modifying business documents, answering phones, and managingcorrespondence
+ Utilizes advanced software skills,including Microsoft Office Suite and other business-specific software such as SharePoint, corporatetravel,procurement, document management, and matter management systems, to effectivelysupporttheorganization
+ Qualified candidates will demonstratetop-notchwritten and verbal communicationskills
+ Practices good judgment and maintains confidentiality in handling sensitive businessinformation
+ Consistently interacts with high-level executives and works with cross-functional teams in connection with projects and division-widesupport
+ Builds strong working relationships and networks with others to drive efficiency into the organizations theysupport
+ Provides basic project management supportand assists with meeting/eventcoordination
+ Conducts onboarding activities, including workspace set-ups for newemployees
+ Prioritizes workload to ensure departmental support needs arefulfilled
+ Maintains departmental files, as assigned, in compliance with corporatepolicy
+ Responsible for compliance with applicable Corporate and Divisional Policies and procedures
**Required Qualifications**
+ High School diploma or equivalent, some collegepreferred
+ 5+ yearsofprevious administrativeexperience or equivalentisrequired
+ Advanced verbal and written communication skills
+ AdvancedexperienceinMicrosoft Office Suite(Teams,PowerPoint, Outlook,Excel,and Word)requiredand SharePoint, SAP, Concur experiencepreferred
+ High level of integrity and professionalism in handling sensitive and confidential information
+ Abilityto effectively manage competing priorities and work independently and as part of ateam
+ Proactive problem solver with strong attention to detail
**On-site role: 5 days per week (not remote)**
**Apply Now**
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is $22.05 - $44.15 per hour. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
Technical Application Specialist I - Midwest/Central US
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with a high employer contribution.
+ Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program, and FreeU (*************************************************************************************************************** education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
The **Technical Application Specialist I** in the **Midwest/Central** territory will provide support to Abbott's Diagnostic Division (ADD) customers and field personnel as the primary contact for ADD's highest complexity instruments for onsite instrument and assay integration and training; and serve as a resource for internal/external customers in troubleshooting and resolving instrument and/or reagent problems onsite or over the phone; and document information into the complaint handling system.
**Territory**
+ This is a remote field-based position.
+ Qualified candidates should live in the Midwest/Central United States, preferably in the areas of Wisconsin, Nebraska or Michigan.
+ Qualified candidates must currently live in the territory preferably near a major airport.
+ Must be able to travel Monday through Friday, with a significant amount of overnight travel.
**What You'll Work On**
+ Responsible for implementing and maintaining the effectiveness of the quality system. Lead multi-site/multi-instrument integrations for ADD instruments and reagents into customer sites/laboratories, including new product launch (NPL) products.
+ Conduct comprehensive customer entrance interview to understand the customer's needs; and manage their expectations within the defined service offerings. Plan the onsite integration process.
+ Work with implementation project managers as technical lead to execute project plan across customer systems.
+ Work with the customer to take ownership of the instrument. Assist customers with meeting their regulatory and validation requirements.
+ Provide appropriate training for the customer on the newly installed instrument.
+ Manage the integration process to meet customer expectations and timeline. Conduct thorough exit interview to present integration results and secure customer buy-in.
+ Lead critical account management situations as part of combined sales/service/support effort.
+ Perform troubleshooting on issues related to reagent or instrument performance designed to improve customer self-sufficiency.
+ Provides technical phone and on-site support to proactively maintain product performance or resolve customer complaints with ADD products for hardware, software, and reagent issues. Investigate problems, diagnose probable causes, systematically eliminate alternatives, provide solutions, document information into complaint handling system.
+ Position is critical to the support of the CAPA Quality Sub-System with responsibility for accurate documentation of customer complaints and the actions taken to resolve those concerns.
+ Recognizes and communicates product issues and potential improvements to others in the organization in a timely and effective manner.
+ Provide immediate feedback to Customer Service Organization; Global Service Support; and others regarding NPL field performance.
+ Deliver onsite or classroom-based customer training.
+ Customize onsite training to meet specific customer needs. Maintain and develop technical competence on instruments assigned as well as job-related tools and processes.
+ Consults in the sales cycle regarding integration/technical/workflow issues, and the service cycle on Highly Serviced Instruments or other account management issues.
+ Manage time, territory; systems and accounts effectively to meet customer needs; organizational priorities, and sales objectives.
+ Follow defined Technical Application Specialist work processes for all aspects of job, including integration procedures, complaint documentation, time documentation, activity documentation, and TOR documentation.
+ Provide data to the organization on customer use/preferences leading to customer driven design/customer usability.
+ Responsible for identifying and communicating critical gaps and recommend potential improvements to cross functional work processes.
+ Function as Subject Matter Expert or point-person on complex processes on cross-functional teams. Provide technical information to direct management/peers and other functional groups.
**Position Accountability / Scope:**
+ This position is a very visible to the external customer and will influence customer purchase decisions. This position is a Subject Matter Expert (SME) for the Technical Application Specialist (TAS) organization to sales and service, influencing stakeholders in these areas.
+ Frequent interaction with customers' onsite and via telephone; SME/leadership roles on teams or major projects. Leadership shared with Field Service, Customer Support Center, or others on critical account management issues.
+ Receives general direction and exercises considerable discretion as to personal work details. Accomplishes results individually, working remotely and in collaboration on teams and work groups.
+ Develops processes and procedures for department. Recognizes the impact of the policies and procedures on the business and raises the issue if there is a potential conflict.
+ Makes decision on reagent utilization on integrations and troubleshooting product replacement that impacts annual supply budget.
+ Considers financial and customer implications as part of decision making.
+ Critical contribution to the effectiveness of the CAPA system with responsibility for accurate documentation of customer complaints and the actions taken to resolve those concerns.
+ Exhibits high level of integrity, honesty, keeping commitments and presenting information completely and accurately to both internal and external customers.
+ Monitor and maintains customer satisfaction through direct contact.
+ Adheres to safety guidelines; policies; procedures.
**Required Qualifications**
+ Bachelor's degree in Science or Medical Technology.
+ 2 years' experience in laboratory environment, field service, technical call center, or Abbott Diagnostics products
**Preferred Requirements**
+ Bachelor's Degree in Medical Technology
+ 4 years' experience in laboratory environment, field service, technical call center, or Abbott Diagnostics products.
Apply Now (******************************
**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** *************************** (***************************************************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at abbott.com , on LinkedIn at ***************************************** , and on Facebook at ************************************** .
The base pay for this position is $60,000.00 - $120,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
Associate Specialist Administration
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
Career development with an international company where you can grow the career you dream of
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
Join our Corporate Human Resources team at Abbott Park, IL, where you'll play a key role in supporting HR operations and enhancing employee experience through thoughtful service and collaboration.
As a, Associate Specialist, Administration, you will support areas of focus within benefits and leave of absence administration with basic knowledge of HR principles:
You will work with supervision and guidance from experienced specialists or managers.
You will be assigned projects that are smaller in scope and complexity.
This role is empowered to surpass expectations by collaborating, anticipating, driving to resolution, and serving with care, compassion, and confidence.
This role takes ownership of the customer experience and must maintain composure in difficult situations.
What You'll Work On :
Issue Resolution: Manage priorities, address escalations, and implement process improvements to ensure successful project outcomes and deliverables.
Analytical Thinking: Evaluate data from multiple sources, assess impacts, and identify interdependencies to proactively resolve or mitigate challenges.
Process Improvement: Identify and implement enhancements to improve customer experience and operational efficiency.
Project Support: Contribute to Program Administration (PA) initiatives aligned with Global HR Services (GHRS) vision and pillars.
Operational Execution: Administer assigned programs with initiative and attention to detail, collaborating with HR Services, Practice Centers, BHR, and Finance.
Cross-Functional Collaboration: Partner across global service centers and HR teams to resolve escalations, identify service gaps, and support program delivery.
Compliance: Adhere to established protocols and promote a compliance-focused mindset by identifying and escalating potential risks.
GHRS Initiatives: Support the development and execution of key GHRS projects on behalf of Program Administration.
Position Accountability & Scope
Reporting Structure:
This position reports to the Manager or Supervisor of Program Administration.
Coordination Responsibilities:
The role involves collaboration across multiple levels of the organization:
Local: Collaborates with US HR Service Center, Program Administration (PA) and other Global HR Services Teams.
Regional: interfaces with Affiliate and divisional HR and Practice Centers including Compensation & Benefits, Talent Acquisition, Talent Development, HR Communications, Talent Management, and HR Finance.
Global: Engages with OUS HR Service Center peers, Global HR Services (GHRS), and the broader HR community.
Required Qualifications
Associate's degree with a minimum of 2 years of relevant experience, or 4 years of relevant experience without a degree.
Experience in administering benefits and leave programs.
Proficiency in English (spoken and written); strong verbal, written, and telephone communication skills.
Multilingual skills in Spanish or French are a plus.
Preferred Qualifications
Proficiency in HR service technologies such as Zendesk and Workday.
Experience in Human Resources, customer service, or project management.
Demonstrated competencies in: Problem-Solving, Analytical thinking, Process Improvement, Collaboration, Communications at all levels, Project Management Support, Self-Directed, Resourceful, Cultural Awareness, Time Management, Prioritization, Relationship Builder, Multitasker, Emotional Intelligence, Empathy, Attention to detail.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is
$50,000.00 - $100,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:HR OperationsDIVISION:CHR Corporate Human ResourcesLOCATION:United States > Abbott Park : AP52ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************
Auto-ApplySite Administrative Assistant
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Responsibilities:
The Administrative Assistant will report to the Site Head-Lilly Kenosha and be responsible for providing schedule, staffing, communication, and office management for direct and indirect business partners across the Kenosha site.
Key Objectives/Deliverables:
Proactively maintain daily calendars for the Site Lead Team; initiate contact and establish good working relationships with others outside of the work group to maximize schedule coordination.
Manage large, complex meetings, audits, recognition events, and/or Town Halls at various locations and of various sizes. Assist in planning logistics by calendaring, identifying/scheduling conference rooms, setting up equipment, ordering materials and/or catering as needed.
Serve as key contact person for the Site Lead Team, helping to build relationships with direct and indirect business partners
Communicate regularly with business partners inside and outside of the Kenosha site
Maintain direct, open, and constant communication with business partners.
Prepare written communication, documents, and presentations
Holistic administration office management activities
Create and maintain group and distribution lists, spreadsheets, documents, presentations, databases, and collaboration sites.
Coordinate and arrange travel, including more complex travel (e.g., international, multi‐city travel) for business partners including (but not limited to) air, hotel, and rental car.
Process complex expense reports (i.e. multi‐currency) including reconciliation of corporate credit accounts used for business purposes in a timely and accurate manner.
Assist with administrative tasks in pre‐boarding and onboarding of new employees and/or contractors
Serve as a resource to the area by explaining corporate and departmental procedures.
Handle additional administrative support or special projects as assigned by the Site Lead Team.
Potentially lead committees or teams, including members of various departments and/or components
Attend various business meetings as needed to understand the business area and priorities.
Obtain and utilize appropriate levels of Lilly process and product knowledge
Basic Qualifications:
High School Diploma or equivalent
Excellent written and verbal communication skills
Strong interpersonal and organizational skills
Ability to maintain confidentiality
Proficient knowledge of Microsoft programs
Knowledge of Travel and Expense Reporting
Problem solving and critical thinking skills
Demonstrated ability to effectively manage complex calendars
Ability to adapt to frequent changes in priorities, to manage multiple diverse tasks, to maintain accuracy, and to meet tight deadlines.
Ability to work independently and confidently with limited guidance from others
Additional Skills/Preferences:
Knowledge of manufacturing organization and operations is preferred
Additional Information:
Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs.
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$18.02 - $35.43
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyEnvironmental Technician
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with high employer contribution
+ Tuition reimbursement, the Freedom 2 Save (******************************************************************************************************* student debt program and FreeU (*************************************************************************************************************** education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our Abbott Park, IL location in the GES Global Engineering Services. This is a 1st shift position.
The Environmental Test Group deals with testing and repair of Clean Room Filtration, Bio Hoods, Bio Suites, Chemical Fume Hoods, Terminal Filters, HEPA Exhaust Housings, Recirculation HEPA Filter Units and Clean Air Centers. The Environmental Test Technician will perform routine testing and work on the most complex ESE systems and equipment including clean rooms and biohazardous facilities. Will troubleshoot mechanical problems and perform all required tasks and make repairs necessary to return the equipment to operation in a timely manner.
**What You'll Work On**
+ Perform advanced mechanical tasks and preventative maintenance (PM) procedures on all ESE equipment, including decontamination of equipment and facilities throughout Abbott Lake County operations.
+ Perform test and balance of clean room systems, terminal filters and labs.
+ Work includes troubleshooting, ordering parts and installation of parts and material on equipment such as: constant volume control boxes, fractional horsepower motors, variable frequency drives, unit circulation fans, and basic electrical devices associated with the control of the units, etc.
+ Perform preventative maintenance work on all types of plant ESE equipment including fans, valves, actuators, etc.
+ May install belts, gaskets, etc. on ESE equipment utilizing a variety of gauges, tools and test equipment including pressure gauges, leak detectors, torque wrenches, multimeters, ammeters, etc.
+ Assist in ensuring that GMP and safe work policies and procedures are followed and maintained at all times in accordance with established company policies.
+ Assist in training Environmental Technicians.
+ Effectively communicate job status to customers.
+ Ensures that adequate information is shared with other work groups when transferring work orders.
+ Participate in work group team meetings and actively look for methods and work processes that improve productivity, reduce costs, and increase customer satisfaction
+ Order material and parts from the stockroom and initiate work orders and various other forms that may be required.
+ Must read and comprehend Corporate Plant Engineering Operations (CPEO) MAOO1 series BOP's.
+ Will be involved with quarterly review and revision (CPEO) MAOO1 series BOP's.
+ An Environmental Testing Technician will have advanced understanding of HVAC theory and application to air handling systems in a commercial and/or industrial environment.
+ Must have knowledge in the use of flow hood, vel grid and pitot tube for test and balancing.
+ Must be an expert in the use of mechanical hand tools and test equipment including multimeters, flow hoods, etc.
+ Will have the knowledge and experience to perform advanced troubleshooting and mechanical repairs on various devices including fans, valves actuators, etc.
+ Must have the knowledge relating to the installation of HVAC and ESE equipment and accessories according to Abbott Engineering Standards.
+ Will understand basic test and balance theories including relationships of total/static/velocity pressure, static losses in ductwork systems, static regain, fan laws, and effective ventilation.
+ On an independent basis, the individual must be able to evaluate the use of various resources and make knowledgeable decisions in regard to safety and company standards and policies.
**Accountability/Scope**
+ The Environmental Testing Technician is required to work in various locations and environments throughout Abbott Lake County site while performing environmental tests and other job-related activities.
+ Some locations contain exposure to noise, chemicals, biohazards, radiation, odors, dirt and dust, humidity, hot and cold temperatures, heights, and confined spaces that require continuous awareness and conformance to safe working procedures and policies.
+ May be required to work outside during inclement weather and adverse working conditions.
+ Errors in judgment while working with more senior trades persons or failure to follow specific safety rules and procedures could result in serious injury to the trades person and others and/or cause significant equipment or property damage.
+ Errors in shutting down bio exhaust and clean room facilities, for example could cause system shutdowns that would create immediate hazards to individuals.
+ Closing valves inappropriately could result in production and/or facility equipment shutdown and result in product losses.
+ Failure to schedule maintenance work with Production Management could have an adverse impact on customers operations/production.
+ Accidentally energizing electrical/mechanical systems and/or equipment could have life or death implications.
**Required Qualifications**
+ Must have a high school education or equivalent.
+ Must have a minimum of 2 years of increasing job knowledge and formal training and responsibility in the field of ESE system maintenance
+ 3+ years of formal training and work experience/responsibility in the field of commercial or industrial HVAC system maintenance. This experience must indicate proficiency in all aspects of maintenance of HVAC system equipment including the demonstrated ability to work well with others in a commercial and/or industrial work environment.
**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ********************** (http://**********************/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at ************** , on Facebook at *********************** and on Twitter @AbbottNews and @AbbottGlobal.
.
The base pay for this position is $22.05 - $44.15 per hour. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
Sr. Principal Engineer - MSAT Visual Inspection
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Sr. Principal Visual Inspection Engineer - Technical Services / Manufacturing Science (TS/MS) role provides technical guidance for visual inspection operations and projects involving existing and new inspection processes.
The role is responsible for teaching, mentoring, and coaching personnel in all aspects relating to visual inspection processes within the Lilly Kenosha County site. The scope of the role includes visual inspection operations for commercially manufactured products at the Kenosha site.
The Visual Inspection Engineer is responsible for the training and qualification program associated with visual inspection, classification of defects, and ensuring overall scientific understanding of the program. This role will also participate in troubleshooting and driving continuous improvement as it relates to the visual inspection program.
The role will regularly interact with peers within the parenteral network and in Global TS/MS to share learnings and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.
Key Objectives/Deliverables:
Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations.
Perform root cause analysis and apply scientific principles and understanding related to defect creation, prevention, and detection.
Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, procedures, processing records, validation protocols and summary reports, defect classifications, technical studies, regulatory submissions, etc.
Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality.
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda.
Serve as technical interface external to the Kenosha site.
Provide audit support, as needed.
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Requirements (Education, Experience, Training):
Bachelors Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or other related scientific discipline
Minimum 10 years of visual inspection experience within the life science industry
Experience in TS/MS, MSAT, Quality, Engineering, or Operations
Experience with data trending and analysis
Previous experience with deviation and change management systems
Preferred attributes but not required:
Ability to analyze complex data and solve problems
Demonstrated successful leadership of cross-functional teams
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
Other Information:
Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
Position will be based out of Kenosha site with ability to travel to Indianapolis and other global Lilly sites as required
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$117,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyAdvisor -Regulatory Compliance and Post Market
Kenosha, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:
This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. This includes but is not limited to; all facets of inspections (PAI/PLI/Surveillance/Post-approval/for-cause) for all global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). Provide support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the need arises including completion of annual changes.
Key Objectives/Deliverables:
In this role the individual provides support that they provide to the different programs are as shown below. Primary focus is compliance support; other duties will depend on business needs.
Compliance Support
* Lead inspection readiness activities
* Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.
* Proficient in application and use of Machine Learning and analytical tools to being continuously in a state of inspection ready.
US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues
* Works with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirements
Global and US Recall / Market Withdrawal
* Supports the coordination of the execution activities related to US product recall and withdrawals.
* Participate in periodic product withdrawal/recall simulations.
* Consult and train local recall coordinators to assure understanding of process for product removal.
* Monitors recall activities of partner organizations globally.
* Provide information for use in various periodic reviews or metrics.
Global and US Product Shortage
* Coordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure.
* Provide information for use in various periodic reviews or metrics.
Drug and Device Establishment Registration
* Determine information required for drug and device establishment registration for all manufacturers of US marketed product, such as importers, agent, and function.
* Update drug and device establishment registrations for changes as required including completion of annual registrations.
US Volume Reporting
* Coordinate and execute annual volume reporting for US
* Provide information for use in various periodic reviews or metrics.
Personal Development and Shared Learning
* Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements
* Continue to gain knowledge vital to provide a greater understanding of GxP requirements
* Participate in applicable external industry groups and forums
Minimum Requirements:
* Bachelor's degree - Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.
* Minimum of 5 years relevant Industry or Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs
Additional Preferences:
* Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketing
* Expertise in data driven approaches to assess site compliance
* Experience in Quality Assurance or GxP function
* Strong compliance knowledge
* Excellent communication and presentation skills: ability to deliver constructive feedback
* Skilled in interpreting and applying standards to diverse situations with strong problem-solving ability
* Ability to work independently and collaboratively with minimal supervision
* Significant experience supporting global inspections and compliance programs
Other Information:
* Maintain awareness of regulatory and industry tends; ensure corporate standards remain current.
* Flexibility to effectively prioritize work activities to meet regulated timelines.
* Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
* Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs).
* Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters.
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements may change over time and may include additional responsibilities not specifically described in the job description.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyDirector/Senior Director, Global Process Owner - Sterility Assurance QMS
Kenosha, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Company Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
Position Brand Description:
The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program.
The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles.
Key Objectives/Deliverables
The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to:
* Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
* Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
* Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
* Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
* Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
* Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
* Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
* Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
* Actively collaborate with enterprise-wide teams on standardized global business processes.
* As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
* Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management.
* Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique
Basic Requirements:
* 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing
* 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
* Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
* Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management.
* Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation)
* Strong written and oral communication skills
* Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
* Approximately 25% travel
Additional Preferences:
* Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
* Experience leading a major multi-site or global functions improvement initiative.
* Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
* Proficiency in addressing operational challenges through structured approaches and innovative solutions.
* Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
* Demonstrated change agility in anticipating and leading others through change and ambiguity.
* Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
* Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
* Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
* Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
* Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
* Demonstrated people management experience.
* Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
* Experience leading a major multisite improvement initiative or driving multisite standardization.
* Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training.
* Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
* Support the establishment of a sterility assurance network or hub in global TSMS
* Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
Education Requirements:
BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $264,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplySr Manager, Quality Assurance - Parenteral (Night Shift)
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Responsibilities:
The Night Shift Sr. Manager, Quality Assurance, will support the start-up and routine operation of the QA organization overseeing Parenteral operations at Lilly's Kenosha, Wisconsin pharmaceutical manufacturing site. Responsibilities include technical and administrative leadership, as well as project management.
Serve as technical resource to review and approve technical documents
Network with cross-functional technical project delivery team to ensure equipment and systems comply with quality requirements and are implemented with a Quality by Design framework
Work with the Associate Director, Quality Assurance to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on the formulation, filling and visual inspection programs
Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production
Manage a team of up to approximately 15 direct reports
Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
Network with global and other parenteral sites to understand best practices and share knowledge
Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management
Support inspection readiness activities
Interact with regulatory agencies during inspections regarding cGMP issues
Ensure data integrity by design
Basic Requirements:
Bachelor's degree in a science, engineering, or related field of study
5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group
Additional Skills/Preferences:
Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification
Strong knowledge of Quality Management Systems and applicable regulatory requirements
Previous experience directly supporting a pharmaceutical manufacturing operation
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Demonstrated technical writing skills
Demonstrated problem-solving and decision-making skills
Previous facility or area start up experience
Previous equipment qualification and process validation experience
Previous experience with highly automated syringe filling, vial filling, and visual inspection equipment
Previous experience with Manufacturing Execution Systems and electronic batch release
CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
Previous experience with deviation and change management systems including Trackwise
Additional Information:
Ability to work 8-hour days - Monday through Friday (Night Shift)
Ability to work overtime as required
Ability to travel 10-25% or potentially relocate during the project phase to support the design and staffing of the facility
May be required to respond to operational issues outside of core business hours and days
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$94,500 - $138,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplySr. Associate-Environmental, Health & Safety
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for an experienced Health, Safety & Environmental (HSE) professional to support our growth in Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments.
The Senior Health, Safety, Environmental (HSE) Associate will be responsible for the development and technical support of HSE systems, processes, and programs at the Lilly Kenosha site. Responsibilities will include but not limited to regulatory and corporate HSE compliance for the site, coordination of all HSE activities for the site, tracking and trending data necessary for the safe operation of Lilly Kenosha, site HSE improvements, and influencing business and strategic planning. The Senior HSE Associate provides coaching to the organization to ensure a safe work environment.
Responsibilities:
Engage site functional areas to champion in achieving an injury free workplace.
Develop, establish, and sustain HSE systems, processes, and programs for the LKC site to support the transition from construction to start up, and to ensure compliance with internal and external requirements
Partner with construction and design build firms to ensure smooth handoff from construction to start up.
Develop and establish HSE programs and procedures for Lilly Kenosha and provide ongoing technical support.
Provide support for all HSE activities at the Lilly Kenosha site including compliance with environmental permits.
Understand and support the HSE event management, CAPA and change control processes, and influence application of the hierarchy of controls to reduce risk, driving toward site and company goals to achieve an injury free workplace.
Provide floor support to multiple operations (this includes auditing, data collection, trending, and supporting local safety teams).
Leverage knowledge of severe injury risk to influence minimization of potential events and increase awareness / knowledge among site resources.
Provide front line Industrial Safety, Industrial Hygiene and Environmental support for the site.
Chair cross-functional safety committees and actively participate in strategic initiatives.
Conduct and lead complex risk assessments, support incident investigations, and regulatory audits.
Mentor and develop staff; design and deliver advanced training programs for all levels of the organization.
Analyze HSE performance data, report trends to senior leadership.
Maintain professional certifications and stay current with emerging HSE regulations and best practices.
Drive a culture of safety through ongoing education, engagement, and continuous improvement.
Basic Qualifications:
Bachelor's degree in occupational health, Safety, Environmental Science, Engineering, or related discipline.
Minimum of 7+ years of progressive HSE experience, preferably in manufacturing or pharmaceutical environments.
Advanced certifications (CSP, CIH, CHMM, or equivalent) strongly preferred.
Demonstrated technical leadership and strategic influence in HSE.
Strong regulatory knowledge (OSHA, EPA, GMP, etc.) and experience with CAPA systems for HSE changes and deviations.
Proven experience influencing lead multidisciplinary teams and manage complex projects.
Excellent communication, analytical, and computer skills.
Experience with greenfield site start-up and GMP operations preferred.
Additional Skills/Preferences:
Prior HSE experience
Strong HSE regulatory knowledge
Experience with CAPA system for HSE changes and deviations
Demonstrated technical leadership skills
Strong communication and computer skills required
GMP operational experience
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $148,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyEngineering Senior Director, Site Expansion
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Engineering Sr. Director, Site Expansion role is a critical role to ensure we continue to make progress towards our mission and our culture. This role will play a critical role in leading the seamless integration of a large site expansion project into the site commercial operation focusing on op
Project delivery and readiness
Deliver engineering support for major expansion project partnering with Lilly Global Project Delivery team to drive efficiency, organizational integration and operational readiness of project integration into the Parenteral manufacturing network
Ensure thorough and meaningful measurement and analytics on key questions, business needs and delivery of key project milestones to help drive the business and better serve our customers
Support site annual strategic planning and business plan processes, ensuring project needs including resources are planned and supported
Lead and manage operational readiness of major expansion project
Building engineering capabilities for site expansion including planning, hiring and onboarding of internal and external resources
Partner closely with Engineering leader at the site to ensure alignment between ongoing operations and project needs
Drive Operational Excellence and Project Management alignment
Lead and facilitate key project meetings and ensure follow up on actions and inform stakeholders
Anticipate and facilitate the resolution of issues that impact key project deliverables
Ensure appropriate governance in place to ensure safety, quality, agility and execution to drive most important work
Monitor the progress on project milestones and collaborate with site project management function ensuring alignment on LKC integrated project schedule and take action to escalate/remove barriers.
Support site to facilitate consistent processes and efficient planning.
Effective Communication
Drive connectivity between sites, functions and networks to ensure alignment of strategic objectives, planning and execution
Establish and manage documentation and communication of key decisions, actions, and key modifications in time, budget, scope, and risks to key stakeholders
Influences senior management, internal and external customers to ensure effective stakeholder management
Requirements (Education, Experience, Training):
Bachelor's degree in engineering
10+ Engineering experience in a parenteral manufacturing site
Experience from onboarding and/or executing larger capital projects
Previous facility or area start up experience
Prior management or leadership experience including leading or working effectively with a cross functional group including network and/or global functions
Excellent interpersonal, written, and oral communication skills
Strong technical aptitude and ability to train and mentor others
Ability to handle multiple competing priorities
Preferred attributes but not required:
Solid understanding of basic requirements of regulatory agencies
Previous experience with parenteral engineering/manufacturing
Previous experience with highly automated equipment
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous equipment qualification and process validation experience
Previous experience with Manufacturing Execution Systems and electronic batch release.
Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
Previous experience with deviation and change management systems including Trackwise
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location.
The anticipated wage for this position is $147,000 - $215,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$147,000 - $215,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyScientist / Principal Scientist - TSMS PAR
Pleasant Prairie, WI job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. #WeAreLilly
Responsibilities:
The Scientist - TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. Upon the start of commercial production, this role's objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The role will also author and execute protocols as well as conduct root cause investigations. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to parenteral manufacturing.
Key Objectives/Deliverables:
Support the assigned Process Team (formulation, filling, or VI) as TSMS representative.
Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team.
Represent Lilly Kenosha County TSMS team for internal and external communications on a regular basis
Lead risk management activities as it pertains to product/process.
Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
Identify opportunities and lead technical projects to improve process control and/or productivity
Serve as interface with upstream suppliers and parenteral product networks
Drive stability strategy for Lilly Kenosha County products.
Provide Audit support as needed.
Identify opportunities and participate in projects to improve process control and/or productivity.
Basic Qualifications:
Bachelor's degree or higher in engineering, packaging science, or related field
Additional Skills/Preferences:
2+ years experience in cGMP manufacturing preferred (validation, engineering, TSMS, operations, QA, etc.)
Pharmaceutical and/or medical device manufacturing experience
Root Cause Investigation Experience
Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise/MasterControl, electronic batch records, and SAP
Demonstrated successful leadership of cross-functional teams
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Additional Information:
Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be required.
This is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the . For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $167,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyManager AQR Quality Program
Abbott job in Park City, IL
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with a high employer contribution
+ Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**
This position works out of our Lake Forest IL facility.
**What You'll Work On**
The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott's Quality System. This includes division / business support and quality expertise and consulting activities.
**_MAIN RESPONSIBILITIES_**
+ Provide leadership and direction for furthering the development of the Abbott-wide Inspection Readiness Program.
+ Act as a strategic partner for ensuring that our business locations are effective in the full life cycle of a third party inspection (preparation, execution, and response).
+ Provide direction and consultation for third-party inspections including the identification and review of outstanding issues, facilitating inspections, liaison training, and promoting effective and professional inspection facilitation.
+ Capable of assessing, and providing meaningful feedback regarding compliance status, effectiveness of management teams, and related quality and operational systems.
+ Provide scheduling and detailed project tasks for assigned sub-teams to ensure milestones are implemented.
+ Review and support creative solutions to key topics and utilize risk management principles.
+ Build and maintain a strategic focus on emerging regulations and their potential impact on Abbott is essential to success in this role.
Serve as a Technical Advisor, Consultant, or Subject Matter Expert including:
+ Technical consultant to business
+ Represent Abbott both internally and externally in key areas
+ Recognized expert (and sought after) both internally and externally
In addition, the following technical skills are preferred:
+ Significant interaction with executive management with accountability for assigned projects.
+ Candidates must have a fundamental understanding of regulatory inspections and quality systems.
+ Proven technical project leader with an emphasis in Inspection Management and Regulations
**Required Qualifications**
Bachelors Degree, 4-year degree in a technical or scientific discipline
_Experience/Background:_ Minimum 10 years
+ Managerial/Supervisory Experience - 4 years
+ Quality Assurance and/or Compliance and/or Analytical Laboratories and/or Manufacturing and/or Operations - 10 years
+ Project Management - 3 years
+ Auditing experience- 2+ years
+ Total combined minimum years of experience required: 10-12 (Not necessarily the sum of the above)
**Apply Now**
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: **********************
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews.
The base pay for this position is $127,300.00 - $254,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************