Quality System Manager
Quality engineer job in Indianapolis, IN
Key Responsibilities
Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements
Oversee document control, change management, deviation handling, CAPA, and training programs
Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections
Ensure compliance across all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines
Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment
Review and approve investigations, deviations, nonconformances, and customer complaints, including root cause analysis and corrective actions
Maintain quality performance metrics and prepare management review reports to monitor system effectiveness
Partner with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain requirements
Review and approve SOPs, validation protocols, and quality agreements
Ensure all associates receive appropriate quality and compliance training
Support continuous improvement initiatives to drive operational excellence and regulatory compliance
Qualifications
Bachelor's degree in Life Sciences, Quality Management, Engineering, or a related field (advanced degree preferred)
5+ years of quality or compliance experience within pharmaceutical manufacturing
Strong knowledge of cGMP, GDP, FDA, and ICH regulations
Experience managing quality systems, audits, and regulatory inspections
Proven ability to interpret and apply regulatory requirements in a regulated logistics environment
Excellent communication, leadership, and problem-solving skills
Proficiency with QMS software and standard business tools
Supplier Quality Specialist
Quality engineer job in Indianapolis, IN
Details:
Job Title: Global Supplier Quality Management
Duration: 12+ Months Contract
Pay Rate- $30 - $38 per hour on W2.
Responsibilities:
The Global Supplier Quality Management (GSQM) contractor is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of Client's new site expansions.
The position ensures that Supply Chain & Affiliates organization provides central execution support in onboarding suppliers, materials, and GMP service providers in a timely manner to support project timelines with new site expansions. The contractor is responsible to partner, consult and interface with business partners to implement across networks and functions to meet business needs.
The GSQM process focus is to provide a globally holistic process in which GMP supplier and GMP service provider's Supplier Quality Management activities are globally consistent, available, and executed by a central function to maintain patient safety, product quality, and technical elements at the highest standard and compliance.
Key Objectives/Deliverables:
The following activities will be performed according to established procedures, guidelines, forms and tools. These responsibilities are not intended to be all-inclusive nor are they all to be performed by one person:
โข Execute supplier quality management process in compliance with Global Quality Standards (GQS305, GQS301 & GQS307) in addition to others, as applicable
โข Assist procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing functions in identifying and managing material suppliers and GMP Service Providers.
โข Execute SAP and TW138 activities in the approved supplier list (ASL) process of suppliers and/or GMP service providers for Client's site expansions on behalf of the sites. Collaborate with SAP Business QA as needed.
โข Collaborate and communicate with manufacturing/affiliate sites across the networks (API / Manufacturing / Packaging / DPEM / APIEM / Devices) to ensure process execution is robust and effective and barriers are escalated.
โข Develop and communicate processes to manage the Global Supplier Quality Management (GSQM) process and related initiatives.
โข Provide support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, VeevaVault (QDocs), TrackWise.
โข Support execution of Certification Package Review Board and global certification packages for global SAP Manufacturing Plants (MPs) materials.
โข Partner with Global TS/MS to develop and execute the material risk control strategy (material risk, product acceptance risk, specification controls).
โข Provide input and support for supplier related change controls.
This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.
Personal Development
โข Be continually aware of current industry trends and regulatory agency interpretation of GMP/cGMP and other relevant requirements, in particular, those related to the Supplier Management Programs.
โข Maintain good interpersonal and communication skills with business areas with emphasis on verbal and technical writing skills.
โข Complete required training and qualifications for the roles identified in the Learning Plan (LP).
Qualifications:
Associate's degree or other advanced education or training
Excellent knowledge in manufacturing operations, quality, and supplier quality management is preferred.
โข Experienced in SAP, TrackWise, and Veeva QualityDocs is preferred.
โข Experienced in Change Management.
โข High ability in execution of MS Office basic suite (Teams, OneNote, OneDrive, Sharepoint, PowerPoint, Excel).
โข Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent interpersonal and oral presentation skillsโฆ. as well as strong written communication skills.
โข Creativity in strategy development and problem solving.
โข Ability to work independently and as part of a team with minimal supervision.
โข Ability to communicate, convince, train.
Additional Skills/Preferences includes:
โข Five (5) years of minimum experience at manufacturing site within QA organization
โข Good knowledge of quality management; Supplier Quality Management; ISO and GMPs
โข PowerApps, PowerBI, Tableau experience
โข Knowledge of GQS, CQP, LQP
Additional Information includes:
โข May require visits to Client's manufacturing sites.
โข Proficient English oral and written skills and experience
Traveling Quality Manager
Quality engineer job in Indianapolis, IN
The primary function of this role is to support the Quality Management System with development and implementation of quality procedures, processes, metrics, audits, and training to improve project quality by recommending correct construction methods to subcontractors and company personnel prior to installation and during installation; identify substandard work; and remedy corrective action during construction. The person in this role will have extensive travel and ensure that all products and services meet requirements through being an integral part of the construction process by means of coaching, educating, and mentoring.
PRIMARY DUTIES AND RESPONSIBILITIES:
Responsible for promoting a safe working environment and setting an example for field personnel.
Conducts periodic Safety Observations and report findings to Site Safety Staff
Develop a good working relationship with project team (management and field).
Develop a good working relationship with job inspectors/owners.
Assist/direct project team in proper storage requirement procedures for all onsite materials.
Assist/direct project team in proper maintenance requirements for all onsite equipment.
Assist/conduct pre-pour conferences/meeting with site teams and clients.
Assist/direct setup and success of field and shop welding activities.
Assist/direct project team in the collection, tracking and filing the required data to ensure compliance with governing specifications/codes.
Create turnover packages.
Job specific pre-pour checklist
Maintenance logs including:
Rotation Logs
Lubrication Logs
Become a SME related to Division 3 specifications.
When specifications are not met, work with the project team and owner to develop a solution.
Conduct random audits, as specified by the Corporate Office, for compliance and adherence to BEC's Quality Program. Utilize the data collected from these audits to assist field operations in determining appropriate improvements.
Assist Corporate Quality Manager in the development and revision of BEC's Quality Program
Conduct source inspections of vendors and subcontractors
Ensure vendors and subcontractors are in compliance with project specifications.
Assist with bid documents and provide recommendations to estimating and project team that comply with BEC's Program, client requirements, manufactures recommends and applicable Code.
Responsible for educating project team.
Inspect and document welding activities.
Witness and document testing activities
Example - 3rd party testing, NDE
Complete daily and monthly reports.
Submit monthly reports NLT the last working day of the month.
Complete Non-Conformance Reports (NCR's) as required and assist team with Quality Short creation.
ESSENTIAL SKILLS AND EXPERIENCE:
BS in Engineering, Construction Management, or Industrial Technology - preferred
Strong written and verbal communication skills.
Previous experience working with project teams, subcontractors, and owners/clients.
Must be able to interpret construction documents.
Previous experience researching corrective options and ability to make recommendations.
NACE, API, ACI, ASME, ASNT and other certification - preferred
BOWEN BENEFITS:
Competitive Base Salary + Company Truck + Annual Bonus
Medical, Dental and Vision Insurance
PTO from Day 1
7 Paid Holidays (plus 6 additional half-days), 1 Community Day, 1 Floating Holiday
Paid Parental Leave
Annual Discretionary Bonuses
Employer-paid Life Insurance with supplemental options
401k with Company Match
HSA and FSA options
Employee Referral Program
Wellness Program
Employee Assistance Program (EAP)
Short and Long-Term Disability
Family Planning and Adoption Assistance
Education Reimbursement
Validation Engineer II
Quality engineer job in Indianapolis, IN
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in _____________.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.
Additional Responsibilities
Write C/Q/V documents following established standards and templates, including but not limited to the following:
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Perform field/site activities including, but not limited to, the following:
Attend and witness FATs and SATs as a representative of IPS clients.
Execution of commissioning forms and witnessing of vendor start-up and testing.
Execution of C/Q/V protocols.
Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons!
Qualifications & Requirements
Bachelor of Science in Engineering.
2+ years of relevant work experience.
This is an entry-level position.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Preferred Qualifications
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
Context & Safety
This position will have up to 100% travel to the site, or as required by the assigned project.
You may be assigned to a client site for an extended period.
Overnight travel or staying in the city of the client's location is possible depending on the assignment.
Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
You may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Senior Process Engineer
Quality engineer job in Indianapolis, IN
Process and Automation Engineer
Domestic & International Travel: Yes, 30-50%
Contract Type: 6-Month Contract-to-Hire
Company: Brooksource Engineering (On-site at a pharmaceutical manufacturing client)
Compensation: $65/hour ++
Position Overview
As a Process and Automation Engineer, you will focus on defining, validating, and optimizing high-speed assembly and packaging processes for pharmaceutical products. This role emphasizes mechanical systems, process characterization, and regulatory compliance while supporting major capital projects for new product launches and capacity expansions. You will collaborate with OEMs and internal teams to ensure robust process design, seamless equipment integration, and adherence to qualification standards (IO/OQ/PQ).
Key Responsibilities
Process Design & Optimization: Develop and refine process flows for automated assembly and packaging lines, ensuring throughput, reliability, and quality.
Equipment Integration Oversight: Partner with OEMs to confirm mechanical and process requirements are met during design and installation.
Engineering Studies & Characterization: Define and execute studies to characterize unit operations, establish operating ranges, and validate process capability.
Risk Analysis & Mitigation: Apply FMEA and other risk assessment tools to identify and mitigate process and patient risks.
Qualification & Validation: Lead or support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for new equipment and processes, ensuring compliance with cGMP and regulatory standards.
Performance Analysis: Use statistical methods and process data to identify bottlenecks, optimize cycle times, and improve efficiency.
Documentation & Compliance: Author and maintain process documentation, including SOPs, process flow diagrams, validation protocols, and qualification reports.
Continuous Improvement: Drive Kaizen and OPEX initiatives to enhance process reliability and reduce cost of goods.
Mentorship: Provide guidance to junior engineers on process validation strategies and best practices.
Minimum Qualifications
Process Engineering Expertise: Experience in mechanical assembly processes, high-speed packaging systems, and process optimization.
Capital Project Delivery: Proven ability to support large-scale process implementation projects in regulated environments.
Validation Knowledge: Hands-on experience with IO/OQ/PQ protocols and execution.
Preferred Qualifications
Familiarity with cGMPs, commissioning, and qualification processes.
Experience with DOE, GR&R, and statistical analysis for process improvement.
Understanding of automation systems and their impact on process performance.
B.S./M.S. in Mechanical, Chemical, or Industrial Engineering (or equivalent experience).
Additional Information
Travel: Up to 25% on average, with peaks exceeding 50% during major project phases.
Validation Engineer
Quality engineer job in Indianapolis, IN
Contract Validation Engineer - Indianapolis, IN (2 year contract)
We are seeking Validation Engineers to join a leading global organization committed to advancing healthcare solutions.
Key Responsibilities
Execute validation activities with a strong focus on drug-handling processes to maintain audit readiness.
Validate critical process parameters for aseptic handling, packaging integrity, and contamination control.
Oversee qualification of equipment and systems supporting drug-handling processes, including cleanrooms and controlled environments.
Develop and maintain validation documentation aligned with GMP, FDA, and EU standards, ensuring data integrity and regulatory compliance.
What We're Looking For
Experience in pharmaceutical validation, particularly in aseptic and drug-handling environments.
Strong understanding of regulatory requirements and quality standards.
Detail-oriented with excellent documentation and problem-solving skills.
Manufacturing Controls Equipment Engineer
Quality engineer job in Greensburg, IN
What Makes a Honda, is Who makes a Honda Honda has a clear vision for the future, and it's a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record success. We strive to be a company that serves as a source of โpowerโ that supports people around the world who are trying to do things based on their own initiative and that helps people expand their own potential. To this end, Honda strives to realize โthe joy and freedom of mobilityโ by developing new technologies and an innovative approach to achieve a โzero environmental footprint.โ
We are looking for qualified individuals with diverse backgrounds, experiences, continuous improvement values, and a strong work ethic to join our team.
If your goals and values align with Honda's, we want you to join our team to Bring the Future!
Job Purpose
Ensure proper implementation of new or modified equipment. Support production equipment to sustain or improve department characteristics, applying electrical controls solutions.
Key Accountabilities
Provide technical support for department equipment to support mass production.
Manage engineering projects to ensure that schedules and targets are achieved.
Design and evaluate electrical control systems to drive department improvements.
Lead and support the review of electrical designs, hardware and software. Ensure proper installation and modification of equipment to relevant electrical standards (NEC, NFPA, etc.)
Lead/support electrical equipment troubleshooting to minimize downtime and maintain production targets.
Lead or support Electrical and PLC troubleshooting to determine root cause and establish countermeasures.
Effectively communicate and document project status, equipment changes, etc.
Develop capability of colleagues and team through training, mentoring, and sharing of experiences in area of technical expertise and understanding for succession planning and to increase team workload capacity.
Support departments initiatives as required
Qualifications, Experience, and Skills
BS in Electrical Engineering or 8 years relevant experience required
2-8 years' experience based on education
Self-Motivated individual that works well with little supervision in addition to working well in a team environment
Experience with Programmable Logic Controllers (PLC)
Experience with Industrial networks (EIP, DeviceNet, etcโฆ)
Fluent in Microsoft Office Package
Aptitude for and knowledge of electro-mechanical manufacturing systems
Short- and long-term project management planning skills.
Ability to lead projects and supervise contractors
Good written and oral communication skills and ability to effectively present information at all levels within the company
AutoCAD design drawing experience
Desired but not Required KSAs: Robotics Experience; Machine Design Experience; Catia (or applicable 3D design software), Pneumatics.
Working Conditions
Primarily work in production office
Work on production floor for installs and troubleshooting
Ability to lift 20 lbs and operate vibrating hand tools
Travel 3-4 times per year or as business needs require
Work weekends and various shifts as needed
Overtime 5-15 hours a week (depending on project)
What differentiates Honda and make us an employer of choice?
Total Rewards:
Competitive Base Salary (pay will be based on several variables that include, but not limited to geographic location, work experience, etc.)
Paid Overtime
Regional Bonus (when applicable)
Industry-leading Benefit Plans (Medical, Dental, Vision, Rx)
Paid time off, including vacation, holidays, shutdown
Company Paid Short-Term and Long-Term Disability
401K Plan with company match + additional contribution
Relocation assistance (if eligible)
Career Growth:
Advancement Opportunities
Career Mobility
Education Reimbursement for Continued Learning
Training and Development programs
Additional Offerings:
Tuition Assistance & Student Loan Repayment
Lifestyle Account
Childcare Reimbursement Account
Elder Care Support
Wellbeing Program
Community Service and Engagement Programs
Product Programs
Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.
Quality of Life Program Manager- Hemophilia- Paragon Healthcare
Quality engineer job in Indianapolis, IN
Be Part of an Extraordinary Team A proud member of the Elevance Health family of companies, Paragon Healthcare brings over 20 years in providing life-saving and life-giving infusible and injectable drug therapies through our specialty pharmacies, our infusion centers, and the home setting.
Title: Quality of Life Program Manager- Paragon
Ideal candidates will be comfortable traveling 60-70% of the time to local Hemophilia chapters across the U.S.
The ability to attend Programs scheduled on nights and weekends will be required.
Field: This field-based role enables associates to primarily operate in the field, traveling to client sites or designated locations as their role requires, with occasional office attendance for meetings or training. This approach ensures flexibility, responsiveness to client needs, and direct, hands-on engagement.
Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law.
Build the Possibilities. Make an Extraordinary Impact.
The Quality of Life Program Manager- Paragon is responsible for developing and implementing innovative ""Quality of Life"" (QOL) programs for individuals with bleeding disorders to drive health outcomes and improve therapy adherence.
How you will make an impact:
Primary duties may include, but are not limited to:
* Collaborate with territory representatives to leading the increased business generation and customer retention.
* Develops and maintain business relationships with local chapters, clinics, and healthcare providers to enhance the business unit presence and impact in respective territories.
* Utilize lifestyle tools and resources within the QOL program to empower patients in managing their health, thus fostering a sense of control over their condition.
* Strategically integrate QOL initiatives into sales efforts to shorten the sales cycle and promote seamless health management solutions for patients.
* Leverage the QOL program as a significant referral source, contributing to business growth while maintaining cost-effectiveness compared to traditional event sponsorships.
* Monitor and evaluate the effectiveness of QOL programs regularly, making data-driven adjustments to ensure optimal patient engagement and satisfaction.
* Collaborate with cross-functional teams to align QOL initiatives with overall company objectives and marketing strategies.
* Travels to worksite and other locations as necessary.
Minimum Requirements:
* Requires a BA/BS and a minimum of 5 years of healthcare; or any combination of education and experience which would provide an equivalent background.
Preferred Skills, Capabilities and Experiences:
* Prior experience as a professional Public Speaker is strongly preferred.
For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $71,544 to $112,194
Locations: Colorado, Washington State
In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws.
* The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law
Job Level:
Non-Management Exempt
Workshift:
Job Family:
SLS > Sales Operations
Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health.
Who We Are
Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve.
How We Work
At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business.
We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few.
Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process.
The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws.
Elevance Health is an Equal Employment Opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
Coordinator External Quality
Quality engineer job in Indianapolis, IN
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
This role provides entry-level support to the Quality department. This role supports the overall quality program and may serve as a liaison between the Quality team and other service lines of Versiti. He/she/they may support other service lines by providing quality input on projects and everyday tasks.
Total Rewards Package
Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Responsibilities
Core Quality Responsibilities * Assists Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Assists Manager in identifying quality system improvements. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * Supports internal/external assessments as assigned. * Prioritize tasks to meet the needs of assigned quality objectives. * May prepares charts, tables, etc. to analyze quality metrics. * Review, analyze, approve, and monitor events logged in event management system.
Specific External Quality Coordinator Responsibilities * Provide support to the supplier quality and contract function(s) with a focus on supplier/ customer/ service development-related projects/initiatives * Support the implementation and maintenance of the Supplier Quality Management process to ensure excellent quality of purchased goods * Initiate and resolve supplier non-conformances including root cause and corrective/preventive actions to hold suppliers accountable to Supplier Corrective Action Request (SCAR) commitments * Initiate and resolve Quality exceptions, root cause investigations, containment/corrective actions, risk-based escalation (as appropriate) * Support continuous improvement initiatives, quality system and procedure adjustments * May perform supplier audits and assess non-conformance / audit findings and participate in closure of supplier actions, as needed * May support the maintenance of the contract management process to ensure a consistent and efficient process for the initiation, negotiation, development, review, execution, documentation, monitoring and modification of contractual agreements * May reviewing incoming material from suppliers, if needed, to determine appropriate disposition
Performs other duties as assigned
Complies with all policies and standards
Qualifications
Education
High School Diploma required
or equivalent required
Associate's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) preferred
Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) preferred
Experience
1-3 years experience required with H.S. diploma required
1-3 years experience required with associates degree required
Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred
Knowledge, Skills and Abilities
Ability to read and interpret documents such as Standard Operating Procedures, safety rules, operating and maintenance instructions, and other department manuals required
Must have basic mathematical aptitude such as adding and subtracting two-digit numbers and multiplication and divisions with 10's and 100's to be used for weight measurement, volume, distance, and money. required
Ability to apply judgment to detailed but very structured written or oral instructions and to deal with problems involving concrete variable in standardized work procedures. required
Able to organize work to provide productive workflow needed in component preparation. required
Good knowledge of Quality Systems, Compliance, Supplier Quality etc. areas achieved through prior study, preferred preferred
Applies knowledge of the principles and practices in a recognized professional field requiring academic preparation required
Applies knowledge of standardized rules, procedures, and operations within own area required
Performs actions based on previously established guidelines required
Excellent oral communication skills required
Proficiency in Microsoft Office required
Possess strong attention to detail required
Possess good interpersonal skills required
Licenses and Certifications
ASQ CQA, ASQ CQT preferred
Tools and Technology
Personal Computer (desktop, laptop, tablet) required
General office equipment (computer, printer, fax, copy machine) required
Microsoft Suite (Word, Excel, PowerPoint) required
Not ready to apply? Connect with us for general consideration.
Auto-ApplyQuality Technician
Quality engineer job in Rushville, IN
Job Description
Job Scope:
The Quality Control Technician is to be proficient in every aspect of performing the functions of this position. The Quality Control Technician's overall responsibility, and objective, is to ensure that all aspects of the SQF, Quality, and Food Safety Programs are followed by all employees, vendors, visitors, etc.
Duties and Responsibilities:
Routinely check operator paperwork for accuracy and completeness.
Routinely check labels, bags, and seals for accuracy.
Assure checks are documented clearly, cross referenced and traceable. Communicate results of routine QA tests to production personnel. Notify supervisory personnel and Quality Control and Food Safety Manager of product quality or plant conditions which may have a negative impact on product quality and work together to correct the situation.
In the case of finished product, perform follow-up testing until situation is corrected and product disposition is resolved in a quality conscious manner.
As directed and trained, conduct various tests for incoming ingredients, including sieve, NIR, moisture, and mycotoxin testing.
Maintain and report hold/reject product and assure its proper disposition.
Collect routine ingredients and finished product samples, as required (detailed in QA Manual).
Train and educate all personnel on quality and food safety practices.
Promptly respond to calls for assistance clearly communicating and ETA of arrival.
Promptly respond to quality/food safety concerns, following up as needed.
Follow First In First Out (FIFO) and enforcing other departments to follow the same process.
Continuously work with and/or assist production, maintenance, and sanitation personnel as needed throughout the shift.
Maintain a clean work environment and stock supplies as needed for next shift.
Ensure, and hold accountable, all personnel, visitors, vendors, etc. comply with all Standard Operating Procedures (SOPs) in addition to all SQF, Quality, and Food Safety Programs.
Maintain accurate, complete, and legible paperwork.
Assist Quality Control and Food Safety Manager with all other duties/tasks as needed.
Be an employee champion who will maintain a strong and positive working relationship with all employees with the utmost integrity, confidentiality, and ethical values.
Additional Job Functions:
Assist in maintaining a positive team environment and good working relationship by maintaining a positive attitude toward all Diamond team members, vendors, and customers.
Participate effectively in a team atmosphere by modeling and promoting conflict resolution, diversity, ethical practices, and organizational citizenship.
Responsible for other duties as deemed necessary by Management.
QUALIFICATIONS:
Must be willing to/have availability to work any shift (day or night shift).
Ability to work independently without immediate direction or oversight. Self-motivated with a high degree of initiative and integrity
Excellent communication skills, both oral and written, to effectively communicate in a professional manner.
Excellent interpersonal skills (communication, listening, team player, cooperative, approachable).
Ability to be organized, flexible, and perform acceptably under pressure.
Must be able to take directions, work efficiently and safely.
Must be able to stand, sit, and walk for long periods including on a catwalk.
Must be capable of lifting, carrying, pushing, and pulling up to 50 pounds routinely.
Must be capable of overhead work and manual dexterity for manipulating or moving objects.
Must be able to climb both stairs and ladders up to a high elevation.
Must be able to balance, stoop, kneel, crouch, and crawl.
Must be able to operate a forklift.
Must be able to perform moderate to heavy labor under constant machine operation and other noise.
Education & Experience Recommendations:
Quality experience at a food processing facility preferred.
High School Diploma or GED required.
Greenwood Innovation Center Process Engineer
Quality engineer job in Greenwood, IN
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.
Responsible for identification and development of equipment, processes, and associated control strategies to support clinical trial recruitment, enrollment, and retention. Accomplishes objectives through portfolio projects or independent research projects. Collaborates with other engineering and business partners to identify opportunities leading to innovative technical solutions.
Responsibilities:
* Defines and develops equipment that supports education, recruitment, and retention for clinical trials
* Supervise the develop, delivery and maintenance of the broader Mobile Research Unit fleet and supporting equipment
* Partner with multiple service providers and contractors to ensure the MRCE (Mobile Research and Community Event) team is fully supported with ancillary services, e.g. remote WiFi
* Partner with the GIC Global Supply and Logistics Services Team to support equipment related issues and projects
* Partner with Health, Safety, and Environmental to ensure Maker Space and shop equipment is aligned with HSE standards and regulations
* Own related change agenda and equipment deviation investigations
* Assist MRCE/GIC team with implementation of various AI initiatives
* Assist other engineers/GIC business partners with misc. projects
* Authors or co-authors technical reports and engineering standards/procedures
* Participates in the coordination, evaluation, review, and implementation of departmental initiatives to promote technical excellence.
* Develops plans and assists in setting group goals and timetables for project work. Communicates progress and proposed changes in project timetables, objectives, or direction. Communicates and collaborates with coworkers and management to meet project team goals and promote technical excellence.
* Stays abreast of current technology by reading appropriate journals and attending conferences and courses and finds opportunities to bring new or improved processing technologies to Lilly. Drives evaluation and implementation of new technology from bench test to commercialization.
* Understands and aligns with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participates in the establishment and maintenance of departmental Quality systems.
* Maintains an awareness of the accurate use and maintenance of processing and laboratory equipment in the development facility. Accurately addresses safety and environmental issues.
* Establishes effective networks with other engineers within and external to Lilly to demonstrate other capabilities for the department (e.g. Facilities, Equipment, Instrumentation, and Data Collection)
* Influences other functional groups (e.g. TS/MS, QA, Operations, etc.) through networking and effective technical presentations.
* Additional responsibilities include evaluating and/or installing new capabilities/technologies and demonstrating internal and external influence to solve problems and benchmark potential solutions.
* Additional responsibilities for experienced engineers include leading organizational critical initiatives and guiding and mentoring junior level engineers.
Basic Qualifications:
* Bachelor degree in Engineering related field.
* 5+ years related industrial experience with Process Engineering with a strong background in equipment design.
Additional Skills and Preferences:
* Creativity, imagination, and the ability to transform ideas into effective processes and practical products.
* Background knowledge of parenteral manufacturing processes and some understanding of stability issues associated with parenteral drug products (e.g. proteins, peptides or genomic medicines) with reasonable mechanical aptitude is highly desired.
* Basic computer skills. Advanced computer skills (e.g. computational modeling, database creation, analysis tool creation, and statistics) are highly desired.
* Excellent oral and written communication skills are essential.
* custom manufactured trucks,
* 3D printing
* woodworking operations
* metal working operations
* mobile medical equipment
* 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
$102,000 - $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-ApplyQuality Technician
Quality engineer job in Greenfield, IN
Job DescriptionMust be able to read tape measure up to 1/8 of an inch. Understand/read blueprints. Working in concrete industry.
Minutemen Staffing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Process Engineer
Quality engineer job in Indianapolis, IN
Major Tool & Machine (MTM) takes great pride in the talented people that come to work here. We offer market leading pay, benefits, optional 4/10 work schedule, quarterly bonus potential and a culture focused on employee engagement.
Our work is essential to the world as we provide CNC machining, manual and robotic welding, engineering, program management, inspection, assembly and cleanroom services on a large scale projects to our customers in the Space, Defense, Energy, Nuclear, and Commercial Industries.
Whether you are looking for a place to put your current strong skills to work in a more challenging, purpose filled environment, or you ultimately want long term professional growth and advancement opportunities, this could be the place for you.
We are seeking a high caliber Process Engineer. In this role, you will prepare estimates and quote new jobs for RFQs and develop work order material and new manufacturing processes for new product launches, based on customer requirements.
Duties:
Complete estimates using VISUAL Manufacturing. Obtain material, subcontract and sublet quotations from materials department as necessary.
Conduct contract review of technical requirements versus quotation and coordinate order acknowledgment with CFT Leader.
Complete quality planning for projects.
Maintain part hierarchy and drawing/revision number documentation.
Provide technical support for manufacturing, material and subcontract/sublet contracting.
Complete disposition, root cause analysis and corrective actions as necessary for non-conformances.
Create fixture and process drawings as necessary
Review and disposition Engineering Change Requests
Conduct job release and post job review meetings.
Participate in performance improvement activities with manufacturing personnel.
Review Customer Change Requests, evaluate cost and delivery impact. Notify Sales and incorporate as necessary.
Maintain electronic job folder.
Requirements:
Bachelor's Degree in Mechanical or Industrial Engineering, Mechanical Engineering Technology, or related field preferred.
Prior Engineering experience developing new manufacturing processes for new product launches.
The ideal candidate will have a strong background in machining, blueprint reading, and GD&T.
3D modeling experience preferred.
Strong computer literacy, written and verbal communication, and project management skills are required.
ABOUT US
Major Tool & Machine (MTM) was founded in 1946, starting with only four employees to support the commercialization of the jet engine following World War II. Today, MTM is a contract manufacturer in Indianapolis, Indiana with a 600,000+ sq ft. manufacturing facility, 400+ skilled employees, best-in-industry business and quality systems, and project management expertise. Located for easy access on the east side of downtown Indianapolis, we are short commute away from most any place in the counties surrounding Indianapolis. Major Tool is a Precinmac company, a portfolio of businesses across the US and Canada that provide similar machining, fabrication and other manufacturing services to customers who provide critical services in turn in their various industries. Our Precinmac values are Trust, Gratitude, Action, Excellence and Growth, with a commitment to live these out daily in our workplaces.
Benefits
Excellent Benefits including three health insurance plan options - with a base plan option requiring ZERO employee paid premium. Dental and vision plans have very reasonable employee premiums. Participants in our health insurance have the onsite clinic available at no additional charge for medical services. All employees can access the mental health services provided in the clinic, For HDHP health insurance options, we contribute to your health savings account (HSA) and offer other flexible spending account (FSA) options. We support your retirement goals with a 401k company match. In addition to work schedule options we provide immediate Paid Time Off (PTO) availability and 10 paid Holidays, Along with in house training programs, we offer educational assistance for coursework that will support your career growth at Major Tool, We care about the health of our employees and provide a tobacco free facility, onsite fitness center and wellness events, short and long term disability and life insurance coverage fully paid.
We are proud to be an Equal Opportunity Employer. We follow all applicable non-discrimination laws relating to employment, including candidates with disability or veteran status.
Auto-ApplyProcess Engineer
Quality engineer job in North Vernon, IN
Martinrea is a diversified global automotive supplier, engaged in the design, development and manufacturing of metal parts, assemblies and modules, complex fluid management systems and aluminum products. We employ approximately 15,000 skilled and motivated people at manufacturing, engineering and technical centers in Canada, the United States, Mexico, Brazil, Germany, Slovakia, Spain and China. Our business strategy leverages world-class technologies, motivated and talented people, and high-quality products. We aim to be the best automotive parts supplier in the world in the products and services we provide our customers.
Are you tired of driving out of town for work? Do you want to make a difference in your community and have a greater work life balance? Martinrea North Vernon; part of the Fluids Division of Martinrea, is currently seeking an experienced Process Engineer. Join our team and stop living to work; work to live with Martinrea North Vernon.
Job Summary:
The Process Engineer position provides professional guidance, leadership, and training to other personnel; is responsible for, but not limited to, planning and coordinating new manufacturing projects; improving manufacturing processes, layouts, and tooling.
Required Minimum Qualifications:
University education in engineering and/or technical field preferred
Engineering in a manufacturing field
Three (3) to five (5) years of OEM manufacturing and support experience (automotive industry preferred).
Critical Success Factors:
Excellent attendance
Work with management to report and monitor process compliance
Collaborate and communicate effectively across different organizational levels, functions, and businesses.
Highly proficient with the full Microsoft Office suite (Excel, Word, Access, PowerPoint, Outlook and Visio).
Excellent communication skills (English written and oral).
Excellent time management and work organizational (prioritization) skills.
Excellent analytical and problem solving skills to resolve new and unique problems.
Ability to grasp modern technology quickly
Responsibilities:
Responsible for creating, maintaining and implementing product Process Flows and Process FMEA's in coordination with quality documents (Control Plans) by following QA-WI-051 " Documentation Requirements"
Participate in APQP and compliance with the program Gate Review processes.
Tooling/Equipment Sourcing and Acceptance Criteria
Tooling/Equipment Run-Off Approval
Mistake proofing Identification and Tracking
Mistake proofing validation
Set-Up Instructions
Monitors project development, approval, and implementation schedules and timelines/Ghantt Charts
Attends builds at customer assembly plant
Familiarity with Ford/GM/Chrysler change processes
AutoCAD
Supports timely completion of all Internal and External customer complaints
Working Conditions
Office Environment
Plant Floor (PPE required)
Effort/Physical Demands
Constant communication with employees, peers, and management
Overtime as required
Health and Safety Responsibilities
Must work in accordance with Health and Safety regulations, Company Rules, Plant Rules, policies and procedures
Must use or wear equipment, protective devices or certain clothing as required by the company
Other Duties:
This is not designed to contain a comprehensive list of duties and responsibilities required for this job. Duties and responsibilities may change at any time with or without notice
Disclaimer:
This job description does not constitute a contract of employment.
Quality Technician II
Quality engineer job in Whiteland, IN
DHL Supply Chain is Hiring! At DHL, you will play a part in one of the world's most essential industries. There has never been a better time to join DHL Supply Chain. In a global business like ours, the opportunities are endless. So, join us. Work with us. Grow with us.
The core responsibilities of this role include:
Ensure accurate checking, inspecting and/or counting of all products for both inbound and outbound departments and ensuring all product is free of damage or defect.
Position: Quality Tech II
Shift: 1st Shift (5a to 1p) M-F
Pay: $20/hr
In addition to the general job description below, the ideal candidate will also possess the following skills and/or experience:
Supply Chain, Quality Control, Auditing, Product Compliance, Material or Product Inspection
A minimum of one (1) years' experience in the following:
* Ensure accurate checking, inspecting and/or counting of all products for both inbound and outbound departments and ensuring all product is free of damage or defect.
* Auditing product and packaging/labeling to maintain highest level of product compliance and accuracy
* Ensure the quantity, quality, labeling, and shipping address of orders correspond to customer specifications or other requirements.
* Experience using a commercial WMS (warehouse management system) such as Blue Yonder, Red Prairie, JDA, SAP, etc.
* Microsoft Office software, including Excel.
Be part of the world's largest logistics company!DHL Supply Chain hasbeen certified as a Great Place to Work in the US and Canada! Our excellent benefits packages includes:
* Affordable medical, dental, and vision coverage available beginning on your 30thday
* PTO program for all associates, including paid holidays and vacation
* 401(k) with generous company match
* Tuition reimbursement program
* Excellent training and career advancement opportunities
Grow your skills. Shape your world.
Role Purpose:
Execute assigned tasks to support establishment, maintenance, alignment and continual improvement of the QA System. Responsible for day-to-day Quality Assurance activities to ensure compliance with governmental regulations, customer requirements, quality assurance policies and procedures and accommodating requests for support.
Key Accountabilities:
* Perform Quality audits, inspections and documentation.
* Perform daily quality assurance activities as required or directed by management.
* Monitor and report level of QMS implementation, compliance and effectiveness through audit activities, observation, review of quality metrics and customer feedback.
* Support QA training for new and existing associates.
* Support coordination of QA license, permit and registration activities.
* Work with Quality Assurance, Ops Performance and Process Improvement teams to progress Quality initiatives.
Required Education and Experience:
* High School Diploma or Equivalent
* Forklift operator certificate or satisfactory completion of forklift training program with the first 30 days of employment
* Associate degree or equivalent in related field of study, preferred
Our Organization is an equal opportunity employer.
#LI-Onsite
#LI-DNI
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Process Engineer
Quality engineer job in Morristown, IN
Working at Freudenberg: We will wow your world!
Responsibilities:
Analyze existing manufacturing and operational processes to identify areas for improvement.
Design, develop, and implement process enhancements that improve quality, reduce waste, and increase throughput.
Collaborate with cross-functional teams including Operations, Quality, Maintenance, and Engineering to drive continuous improvement initiatives.
Develop and maintain process documentation including work instructions, process flow diagrams, and standard operating procedures.
Monitor process performance using KPIs and data analytics; recommend corrective actions as needed.
Support capital projects and equipment upgrades by providing process input and validation.
Lead root cause analysis and problem-solving efforts for process-related issues.
Ensure compliance with safety, environmental, and regulatory standards in all process changes.
Train and mentor operations staff on new processes and improvements.
Qualifications:
Bachelor's degree in Engineering (Mechanical, Industrial, Chemical, or related field).
3+ years of experience in process engineering or manufacturing environment.
Strong analytical and problem-solving skills.
Proficiency in process mapping, Lean, Six Sigma, or other continuous improvement methodologies.
Experience with data analysis tools and manufacturing software (e.g., ERP, MES).
Excellent communication and collaboration skills.
Ability to manage multiple projects and priorities in a fast-paced environment.
Communication & Collaboration: Communicates clearly and concisely, while engaging proactively with colleagues at all levels of the organization.
Value for Customers: Anticipates, understands and meets internal/external customers' needs and expectations. Develops solutions based on a customer centric approach.
Innovation: Drives and supports innovative ideas, while taking informed risks to seek and develop new or improved solutions.
Drive & Execution: Proactively identifies what needs to be done and takes action. Explores new ways and pursues new opportunities.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg-NOK General Partnership
Auto-ApplyQuality Assurance Manager
Quality engineer job in Indianapolis, IN
Responsibilities
Drive the development and continuous improvement of the quality culture, strategy, policies, objectives, and processes supporting Quality Assurance in partnership with clients.
Interpret and apply applicable GxP regulations and internal quality policies to complex and unique operational scenarios.
Manage internal and external audits, routine and non-routine assessments, and quality projects related to regulatory inspections and potential non-compliance.
Partner with operations leadership to manage resources, priorities, schedules, and projects to ensure delivery of operational quality objectives.
Lead projects, programs, and team development activities with GxP compliance implications.
Foster a quality-focused environment that enhances employee engagement, productivity, and client value.
Develop and maintain warehouse operations team capabilities to ensure ongoing compliance with evolving regulatory and client quality expectations.
Direct the activities of direct reports and/or lead matrix teams or business processes to support effective quality program management.
Actively engage in risk management by identifying, escalating, and mitigating quality and compliance risks.
Serve as a coach, mentor, and trainer to instill a strong commitment to quality across the organization.
Proactively identify, communicate, and monitor regulatory and business changes that may impact quality performance.
Provide data-driven recommendations and solutions that demonstrate measurable quality improvement and value to internal and external stakeholders.
Participate in strategic and operational decision-making on behalf of client quality interests.
Provide leadership with regular updates on quality performance metrics and trends.
Prepare and present account-level quality performance summaries on a recurring basis.
Serve as the quality lead for new and existing client accounts, including assessment of quality programs and available metrics.
Plan, manage, and coordinate quality audits and regulatory inspections.
Represent the organization in customer meetings and business reviews related to quality performance.
Monitor critical quality attributes and process performance, recommending updates to policies and procedures to maintain best-in-class quality standards.
Act as the primary point of contact for client quality-related requests, including reporting, investigations, training, inspections, and CAPA activities.
Ensure timely and effective responses to routine and non-routine client requests related to data, reporting, investigations, and quality initiatives.
Review and analyze quality and performance metrics to ensure adherence to company and client standards and to drive continuous operational improvement.
Qualifications
Demonstrated leadership capability with the ability to influence and lead within an operations environment.
Strong expertise in Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices as applied to pharmaceutical distribution.
Excellent planning and organizational skills with a strong attention to detail.
Strong verbal and written communication skills with the ability to clearly and persuasively convey ideas and data; Spanish fluency is a plus.
Proven analytical skills with the ability to assess complex data sets and make critical decisions related to product quality and regulatory risk.
Ability to build strong professional relationships and collaborate effectively across cross-functional and interdisciplinary teams.
Proactive mindset with the ability to anticipate risks, investigate root causes, and implement preventative actions.
Broad regulatory knowledge, including U.S. and international regulations such as FDA 21 CFR Parts 11, 205, and 211; EU cGMP and GDP guidelines; USP standards; and related regulatory frameworks.
Quality Technician - Night Shift
Quality engineer job in Rushville, IN
Job Scope:
The Quality Control Technician is to be proficient in every aspect of performing the functions of this position. The Quality Control Technician's overall responsibility, and objective, is to ensure that all aspects of the SQF, Quality, and Food Safety Programs are followed by all employees, vendors, visitors, etc.
Duties and Responsibilities:
Routinely check operator paperwork for accuracy and completeness.
Routinely check labels, bags, and seals for accuracy.
Assure checks are documented clearly, cross referenced and traceable. Communicate results of routine QA tests to production personnel. Notify supervisory personnel and Quality Control and Food Safety Manager of product quality or plant conditions which may have a negative impact on product quality and work together to correct the situation.
In the case of finished product, perform follow-up testing until situation is corrected and product disposition is resolved in a quality conscious manner.
As directed and trained, conduct various tests for incoming ingredients, including sieve, NIR, moisture, and mycotoxin testing.
Maintain and report hold/reject product and assure its proper disposition.
Collect routine ingredients and finished product samples, as required (detailed in QA Manual).
Train and educate all personnel on quality and food safety practices.
Promptly respond to calls for assistance clearly communicating and ETA of arrival.
Promptly respond to quality/food safety concerns, following up as needed.
Follow First In First Out (FIFO) and enforcing other departments to follow the same process.
Continuously work with and/or assist production, maintenance, and sanitation personnel as needed throughout the shift.
Maintain a clean work environment and stock supplies as needed for next shift.
Ensure, and hold accountable, all personnel, visitors, vendors, etc. comply with all Standard Operating Procedures (SOPs) in addition to all SQF, Quality, and Food Safety Programs.
Maintain accurate, complete, and legible paperwork.
Assist Quality Control and Food Safety Manager with all other duties/tasks as needed.
Be an employee champion who will maintain a strong and positive working relationship with all employees with the utmost integrity, confidentiality, and ethical values.
Additional Job Functions:
Assist in maintaining a positive team environment and good working relationship by maintaining a positive attitude toward all Diamond team members, vendors, and customers.
Participate effectively in a team atmosphere by modeling and promoting conflict resolution, diversity, ethical practices, and organizational citizenship.
Responsible for other duties as deemed necessary by Management.
QUALIFICATIONS:
Must be willing to/have availability to work any shift (day or night shift).
Ability to work independently without immediate direction or oversight. Self-motivated with a high degree of initiative and integrity
Excellent communication skills, both oral and written, to effectively communicate in a professional manner.
Excellent interpersonal skills (communication, listening, team player, cooperative, approachable).
Ability to be organized, flexible, and perform acceptably under pressure.
Must be able to take directions, work efficiently and safely.
Must be able to stand, sit, and walk for long periods including on a catwalk.
Must be capable of lifting, carrying, pushing, and pulling up to 50 pounds routinely.
Must be capable of overhead work and manual dexterity for manipulating or moving objects.
Must be able to climb both stairs and ladders up to a high elevation.
Must be able to balance, stoop, kneel, crouch, and crawl.
Must be able to operate a forklift.
Must be able to perform moderate to heavy labor under constant machine operation and other noise.
Education & Experience Recommendations:
Quality experience at a food processing facility preferred.
High School Diploma or GED required.
Greenwood Innovation Center Process Engineer
Quality engineer job in Greenwood, IN
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.
Responsible for identification and development of equipment, processes, and associated control strategies to support clinical trial recruitment, enrollment, and retention. Accomplishes objectives through portfolio projects or independent research projects. Collaborates with other engineering and business partners to identify opportunities leading to innovative technical solutions.
Responsibilities:
Defines and develops equipment that supports education, recruitment, and retention for clinical trials
Supervise the develop, delivery and maintenance of the broader Mobile Research Unit fleet and supporting equipment
Partner with multiple service providers and contractors to ensure the MRCE (Mobile Research and Community Event) team is fully supported with ancillary services, e.g. remote WiFi
Partner with the GIC Global Supply and Logistics Services Team to support equipment related issues and projects
Partner with Health, Safety, and Environmental to ensure Maker Space and shop equipment is aligned with HSE standards and regulations
Own related change agenda and equipment deviation investigations
Assist MRCE/GIC team with implementation of various AI initiatives
Assist other engineers/GIC business partners with misc. projects
Authors or co-authors technical reports and engineering standards/procedures
Participates in the coordination, evaluation, review, and implementation of departmental initiatives to promote technical excellence.
Develops plans and assists in setting group goals and timetables for project work. Communicates progress and proposed changes in project timetables, objectives, or direction. Communicates and collaborates with coworkers and management to meet project team goals and promote technical excellence.
Stays abreast of current technology by reading appropriate journals and attending conferences and courses and finds opportunities to bring new or improved processing technologies to Lilly. Drives evaluation and implementation of new technology from bench test to commercialization.
Understands and aligns with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participates in the establishment and maintenance of departmental Quality systems.
Maintains an awareness of the accurate use and maintenance of processing and laboratory equipment in the development facility. Accurately addresses safety and environmental issues.
Establishes effective networks with other engineers within and external to Lilly to demonstrate other capabilities for the department (e.g. Facilities, Equipment, Instrumentation, and Data Collection)
Influences other functional groups (e.g. TS/MS, QA, Operations, etc.) through networking and effective technical presentations.
Additional responsibilities include evaluating and/or installing new capabilities/technologies and demonstrating internal and external influence to solve problems and benchmark potential solutions.
Additional responsibilities for experienced engineers include leading organizational critical initiatives and guiding and mentoring junior level engineers.
Basic Qualifications:
Bachelor degree in Engineering related field.
5+ years related industrial experience with Process Engineering with a strong background in equipment design.
Additional Skills and Preferences:
Creativity, imagination, and the ability to transform ideas into effective processes and practical products.
Background knowledge of parenteral manufacturing processes and some understanding of stability issues associated with parenteral drug products (e.g. proteins, peptides or genomic medicines) with reasonable mechanical aptitude is highly desired.
Basic computer skills. Advanced computer skills (e.g. computational modeling, database creation, analysis tool creation, and statistics) are highly desired.
Excellent oral and written communication skills are essential.
custom manufactured trucks,
3D printing
woodworking operations
metal working operations
mobile medical equipment
ยท
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
$102,000 - $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-ApplyProcess Engineer
Quality engineer job in Morristown, IN
* Analyze existing manufacturing and operational processes to identify areas for improvement. * Design, develop, and implement process enhancements that improve quality, reduce waste, and increase throughput. * Collaborate with cross-functional teams including Operations, Quality, Maintenance, and Engineering to drive continuous improvement initiatives.
* Develop and maintain process documentation including work instructions, process flow diagrams, and standard operating procedures.
* Monitor process performance using KPIs and data analytics; recommend corrective actions as needed.
* Support capital projects and equipment upgrades by providing process input and validation.
* Lead root cause analysis and problem-solving efforts for process-related issues.
* Ensure compliance with safety, environmental, and regulatory standards in all process changes.
* Train and mentor operations staff on new processes and improvements.
Qualificationsarrow_right
* Bachelor's degree in Engineering (Mechanical, Industrial, Chemical, or related field).
* 3+ years of experience in process engineering or manufacturing environment.
* Strong analytical and problem-solving skills.
* Proficiency in process mapping, Lean, Six Sigma, or other continuous improvement methodologies.
* Experience with data analysis tools and manufacturing software (e.g., ERP, MES).
* Excellent communication and collaboration skills.
* Ability to manage multiple projects and priorities in a fast-paced environment.
* Communication & Collaboration: Communicates clearly and concisely, while engaging proactively with colleagues at all levels of the organization.
* Value for Customers: Anticipates, understands and meets internal/external customers' needs and expectations. Develops solutions based on a customer centric approach.
* Innovation: Drives and supports innovative ideas, while taking informed risks to seek and develop new or improved solutions.
* Drive & Execution: Proactively identifies what needs to be done and takes action. Explores new ways and pursues new opportunities.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.