Quality Assurance Manager jobs at Bristol-Myers Squibb

- 415 jobs

Senior Customer Quality Operations Professional
Pfizer 4.5
McPherson, KS jobs
Use Your Power for Purpose The Senior Customer Quality Operations Professional is the sole responsible colleague for providing quality support related to PGS McPherson Pfizer CentreOne contract manufacturing customers. Responsible for both new business and commercial accounts. Colleague will be required to support multiple customers, can multi-task through each customer issue/requests, work with site SMEs for each activity as needed and represent Pfizer in a professional manner. This position functions as a member of the Quality Assurance Internal & External Supply Group that supports quality assurance for the site, suppliers that support the site and Customers that the site contract manufactures for. This individual will act as Project Lead for Quality Systems to collaborate with customers and cross-functionally throughout the facility to ensure delivery of Quality Product for our Customers. This role will also have additional responsibilities to drive systems for the team and act as oversight for Customer Quality Operations Professionals on the team. What You Will Achieve Lead discussion with Customers on the Quality aspects of all manufacturing processes specific to assigned Pfizer CentreOne customers. These processes include but are not limited to supplier qualification, manufacturing, packaging, lab testing, release, shipping, market distribution, complaints, regulatory filings and market action. Quality Project lead for all contract reviews, creation of new quality technical agreements, assurance of site capabilities as it pertains to quality processes, understanding of development activities and identification of issues for escalation and initial quality audits. Oversee systems of Continuous Improvements for Customer Quality Operation Professionals and additional responsibilities to drive performance. Lead Quality Resource for new customer due diligence meetings and quality audits. Responsible for Quality assessment of all new customer proposals. Develop and Trend quality metrics for each individual Pfizer CentreOne customers. Project lead for areas for improvement through the metrics and driving continuous improvement opportunities to present to the customers and implementation. Draft, negotiate, and gain approval of the Quality Technical Agreement between Pfizer and the customer. Ensure the terms within the agreement are met by both parties. Perform a periodic review of the agreement and update as required. Provide support for and coordinate Pfizer CentreOne customer manufacturing investigations. This will include assessment of scope, input of customer specific information/data, quality impact, escalation and review/approval. Perform communication, tracking and closure of manufacturing investigations, change requests and CAPAs for Pfizer CentreOne Customer specific records. Responsible for quality escalation and issue resolution as it impacts assigned Pfizer CentreOne customers. Support and participate in customer audits and regulatory inspections. Lead Projects between Pfizer CentreOne customers and plant quality functions specific to assigned customers. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards Strong oral and written communication, presentation and interpersonal skills Working knowledge of PC and Software (MS Office) Strong analytical skills required. Must be capable of organizing and analyzing data from multiple sources and extracting key information to achieve goals. Bonus Points If You Have (Preferred Requirements) Previous experience in internal assessment program, auditing, and/or walkthrough audits Production operations and/or Laboratory knowledge preferred PHYSICAL/MENTAL REQUIREMENTS Ability to stand for 1 hour a time, sit for 2 to 3 hours a time. Require working in an office stetting where sitting and computer usage would be typical. may include walking throughout site to support Regulatory Inspection activities. Requires tactful, persuasive, and assertive interpersonal skills and the ability to work both independently and with teams. Requires training for controlled environments within the facility to help facilitate walkthroughs audits. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays. Other Job Details: Work Location Assignment: Hybrid Last day to apply: December 17th The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and Control
$80.3k-133.9k yearly Auto-Apply 3d ago
Quality Assurance Manager
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ jobs
JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
$75k-105k yearly est. 1d ago
Quality Assurance Manager
Hikma Pharmaceuticals 4.9
Dayton, NJ jobs
JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
$75k-106k yearly est. 1d ago
Quality Control Manager
STAQ Pharma 3.7
Denver, CO jobs
STAQ is currently hiring for a Quality Control Manager in the Denver area Monday to Friday, 8 AM to 5 PM Salary: $105K-$110K/year STAQ Pharma is a 503B Outsourcing Facility located in Denver. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ's ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team. This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. Roles and Responsibilities Establish an environmental monitoring program for the facility utilizing a risk-based approach to new and existing procedures. Develop, manage, and improve QC processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B). Prepare, review, manage, and approve controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations. Lead and draft investigations/deviations/change controls/OOS/CAPAs as they relate to environmental monitoring or Quality Control deviations. Provide expertise and support to the Operations, Regulatory, and Quality teams. Subject matter expert during audits or inspections as it relates to microbiology/environmental monitoring. Recruit, retain, and mentor direct reports to comprise the QC team. Promote personal and professional growth of team members. Support the batch disposition process including management of reserve samples and QC samples for batch release testing. Manage the budget for the QC Lab department to meet financial objectives. Lead the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc. Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories. Coordinate and facilitate operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. Analyze and interpret trends and identify opportunities to improve processes and achieve state of control. Focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up, and ability to make timely and sound decisions. Implement methods of continuous improvement in daily work and in evaluation of company processes and performance. Other duties as assigned. Preferred Qualifications and Education B.S. or B.A. in Microbiology or a closely related field / or equivalent experience. Minimum five (5) years' experience in a quality control environment. Experience in a cGMP pharmaceutical/aseptic manufacturing environment. Must demonstrate understanding and/or working knowledge of regulations/guidelines such as FDA, USP, ICH, etc. Proficiency/experience with environmental monitoring program for aseptic manufacturing facility, including personnel monitoring, and qualification program. Preferred Experience and Skills Working knowledge of aseptic/sterile manufacturing techniques. Ability to coordinate multiple priorities in a fast-paced environment. Strong communication skills with the ability to interact with all levels across the organization. Demonstrated excellent interpersonal skills and flexibility. Familiarity with 21 CFR Part 11/210/211. Additional Notes Join a dynamic team at the leading edge as we build out a new 137K sq. ft. manufacturing facility. This position will work closely with cross functional teams and report quality data to the department heads for each team, as needed Timeline: We will be accepting applications on an ongoing basis until position is filled.
$105k-110k yearly 4d ago
Quality Manager Representative
Biolife Plasma Services Careers 4.0
New York jobs
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE Monitors all systems and activities to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Authorized and responsible to cease operations within the center or stop source plasma shipment(s) if product or donor safety is or may be compromised. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Regulatory Compliance: (15%) Stays current with federal, state, local and company-specific rules, regulations, and practices. Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety. Ensures that SOP's are current and that staff perform routine tasks according to SOP through direct observation. Plasma Collection Center Quality Assurance Oversight: (80%) Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations and trending in operating procedures and policies through established mechanisms. Reports errors, deficiencies, discrepancies and observations to center management and the Regional Quality Manager. May stop operations or shipments when donor or product safety is or may be compromised. Identifies potential SOP revisions as needed to support continuous improvement. Works in collaboration with center manager and management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of audit observations. Tracks responses to and evaluates effectiveness of corrective actions for errors. Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Coordinates management review meetings and participates in center staff meetings. Employee Recruitment and Retention: (5%) Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases. Fosters teamwork. Works collaboratively with staff, peers, and management to achieve business goals. Communicates continuously and resolves conflicts proactively. Provides timely feedback on performance and initiates disciplinary action when necessary. Participates in the evaluation and review of center staff. Ensures high levels of customer service and satisfaction. Meets and strives to exceed customer expectations. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Minimum of one-year relevant work experience, or an equivalent combination of education and experience. Relevant work experience within medical or regulated field, highly desirable. Previous work experience within the plasma collection industry is strongly preferred. Computer skills in word processing, excel, data analysis and databases highly desirable. Demonstrated understanding of quality assurance in an FDA-regulated environment. Demonstrated understanding of plasma center operations. Effective organizational, technical and problem-solving skills. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Refers to Group/Regional Lead for guidance on complex, high-impact or urgent decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Consults and coordinates directly with the Center Manager on quality concerns within the plasma center. Advises and coordinates will all other center roles to effectively problem solve, mitigate risk, ensure safety of staff and donors, and provide an exceptional customer experience. Attend staff meetings and other team meetings as required. Attention to detail and ability to work independently Effective coaching and counseling skills. Innovation May participate in the management of projects and new initiatives within the center or across centers. Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Complexity Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Production environment oversight. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required. Desired: Associates or Bachelor's degree highly desirable. ADDITIONAL INFORMATION FLSA Classification (US) - Exempt Other duties and responsibilities as assigned. BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NY - Latham U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - NY - LathamWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes
$75k-108k yearly est. 2d ago
Manager, Clinical Quality Assurance
Summit Therapeutics Plc 4.5
Menlo Park, CA jobs
Site 4 days per week at our Menlo Park CA Princeton NJ or Miami FL Summit Summit Therapeutics Inc is a biopharmaceutical oncology company with a mission focused on improving quality of life increasing potential duration of life and resolving serious unmet medical needs At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKI HARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLC HARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC Colorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The Manager Clinical QA will collaborate closely with Regulatory Affairs QA R&D and other cross functional teams within the Company to provide GCPGLPGPV and compliance related advice to internal clinical study teams This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary taking the lead in ensuring project related procedural documents comply to relevant GxPs and regulatory requirements and guidelines Role and Responsibilities Partnering and collaborating with key stakeholders R&D teams to ensure that appropriate Quality support is provided to Summit Clinical and pre clinical programs Ensuring end to end quality management through proactive compliance based on Clinical Development Plan CDP Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions Supporting CRO relevant meetings when necessary to provide quality overview training to relevant stakeholders Providing support during the development and execution of Corrective and Preventive Actions CAPAs Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined implemented and closed Support formal investigations of issues as they arise ensuring timely escalation to line management if critical incidents are not resolved in due course Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary QA support in interactions with internal and external contacts and Health Authorities HA as appropriate In collaboration with the Global QA team ensure inspection management by assisting in preparing program teams for FDA EU and key HA pre approval and sponsor monitor inspections; provide inspection management support and follow up post inspections Support in providing interpretation of regulations and company process standards guidelines policies and procedures to personnel for assigned programs or for continuous improvement projects Supporting or leading development and driving the implementation of studyprogram specific quality plans to ensure proactive management of quality Supporting rectifying any necessary vendor relevant issues identified for the assigned program Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders Perform internal audits as applicable All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors Degree in Life Sciences Pharmacy or Nursing required Masters Degree or other advanced degree preferred Minimum of 5 or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred Thorough understanding of international GCPGLP regulations including FDAEU GCP ICH pharmacovigilance new drug regulations other key HA guidances and current industry practice preferred Ability to travel up to 20Proficient user of standard MS Office suite eg Word Excel experience using electronic document management systems and document review tools desirable Strong computer and database skills Attention to detail accuracy and confidentiality Clear and concise oral and written communication skills Excellent organizational skills Critical thinking problem solving ability to work independently Must be able to effectively multi task and manage time sensitive and highly confidential documents Communicate effectively and articulate complex ideas in an easily understandable way Prioritize conflicting demands Work in a fast paced demanding and collaborative environment The pay range for this role is 139000 163000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team at recruitingsmmttxcom to obtain prior written authorization before referring any candidates to Summit
$104k-159k yearly est. 5d ago
Quality Assurance Manager - Princeton, NJ
DSM 4.3
Princeton, NJ jobs
Quality Assurance Manager Princeton, NJ Step into a pivotal role where you'll champion quality assurance and shape a First-Time-Right culture at our Princeton Perfumery & Beauty site. As the voice of quality, you'll lead a committed local team and collaborate closely with internal partners and external clients to ensure excellence across every stage of delivery. This is your chance to make a meaningful impact in a fast-paced, dynamic industry while expanding your expertise and influence. If you're ready to drive end-to-end quality and elevate standards, we want to hear from you. Your key responsibilities * Non conformances management expert: Lead Customer (product / service) and / Internal site Non conformances and follow up on any related actions/projects in coordination with appropriate site partners. Tasks include customer communication, investigation and CAPA (correction and preventive action) definition, validation, and verification. * Continuous improvement enhancer: Analyze Quality data and be a solution partner to improve Quality and reinforce end-to-end Quality/ Product protection - Culture and Performance. Lead Projects linked with Quality / Product Protection and support Operations Projects Develop and deliver Quality/Product protection trainings with the support of our Operations training department. * Quality Management System expert: Maintain the Local Quality System supporting end to end robustness of our processes and successful ISO 9001 and be part of the site Audit program: Internal, Clients and Suppliers audits. * Training of applicable Quality Assurance projects * Build relationships with internal and external customers to understand their requirements and answer their requests in a timely fashion. * Support the Quality organization by providing sensory expertise to grow the team's skillset and provide support in sensory related non-conformances. We bring * Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen * A chance to impact millions of consumers every day - sustainability embedded in all we do * A science led company, cutting edge research and creativity everywhere - from biotech breakthroughs to sustainability game-changers, you'll work on what's next * Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership * A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on. * A community where your voice matters - it is essential to serve our customers well. You bring * Bachelor's degree in Chemistry/Quality or related scientific field. * • 5+ years of experience in a quality or regulatory related role * Extensive background in perfumery ingredients and formulations highly preferred * Sensory experience in Perfumery industry highly preferred * 5+ years leadership skills preferred. The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Salary $130,000 - $140,000. In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements. About dsm-firmenich At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, belonging and equal opportunity statement At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
$130k-140k yearly 7d ago
Manager, Quality Assurance
Hikma Pharmaceuticals 4.9
Cherry Hill, NJ jobs
Job Title: Manager, Quality Assurance Reports to: Sr Director, Quality Operations Department: Quality JOB PURPOSE Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, directs batch record review, control and release, investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Responsible for approving all the Change Controls (initial and final reviews), getting all the batch record documents approved after revision, providing QA related metrics to different levels of the organization. Work closely with compliance group at times of external audits (FDA or vendors). Responsible for directing and managing people and systems that assure product quality. Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES * Regular and predictable onsite attendance and punctuality. * Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner. * Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches. * Places lots on HOLD if Quality issues are detected and notifies senior management. * Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner. * Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements. * Conducts routine investigation and departmental meetings to facilitate the performance of release function. * Manages personnel for in-process filling and inspection/packaging monitoring. * Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise. * Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control. * Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization. * Performs QA review and approval of LIR's (Laboratory Investigation Reports). * Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. * Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments. * Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. * Assists the QA management in developing on department budget. * Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. * Manages attendance records for all direct reports. COMMUNICATIONS & WORKING RELATIONSHIPS Internal * Routinely coordinates with supply chain, clean room manager and packaging manager to ensure release priorities are met and appropriate coverage for the operations QUALIFICATIONS, EXPERIENCE, & SKILLS QUALIFICATIONS * Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field * Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE * Minimum: Five years of professional experience in Compounding Facilities/Pharmaceutical Industry SKILLS * Must have history of strong documentation skills and attention to detail * Familiarity with cGMPs and CFR for US and EU * Excellent organizational skills and ability to multi-task and perform work in a timely manner * Demonstrates ability to lead a department, projects and meetings effectively * Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management * General computer skills and ability to prepare presentations and address large groups * Demonstrated attention to details and accuracy * The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must * Mentoring abilities as well as effective communication, (written and oral) are required Location: Cherry Hill, NJ, US, 08003 Nearest Major Market: Philadelphia
$75k-105k yearly est. Auto-Apply 15d ago
Manager, QA Compliance & Validation
Capsugel Holdings Us 4.6
Bend, OR jobs
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lonza Pharma & Biotech is looking for a Manager, QA Compliance & Validation to join our Quality Assurance team in Bend, OR. This is an exciting opportunity to lead a high-performing QA team and ensure compliance across pharmaceutical development and manufacturing. Your work will help shape processes that improve lives worldwide. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Competitive compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to global benefits: *************************************** Key Responsibilities: Support internal and external audits and regulatory inspections as a QA expert. Train staff on cGMP and regulatory standards. Oversee compliance evaluations for development and manufacturing activities. Identify and validate corrective and preventive actions (CAPA). Develop workflows and compliance metrics to improve efficiency. Supervise QA staff and manage quality systems documentation. Review and approve regulatory documents. Key Requirements: Bachelor's degree or equivalent experience. Significant experience in the pharmaceutical or biotech industry. Strong compliance and regulatory knowledge. Prior management experience with leadership skills. Familiarity with GMP (Good Manufacturing Practices) preferred. Excellent communication and collaboration skills. Ability to work independently and as part of a team. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
$76k-117k yearly est. Auto-Apply 26d ago
Quality Assurance Manager
BD Systems 4.5
El Paso, TX jobs
SummaryThe Quality Assurance Manager is responsible for strategic oversight and leadership direction within the Production QA function to include In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Supplier Quality while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures. Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities: Effective implementation of the site QMS Responsible for strategic oversight and leadership direction of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation and Supplier Quality. Knowledge of FDA regulatory requirements (QSRs - 21 CFR Part 820) Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.) Responsible for Production and Process Controls from a Quality perspective Serves as a technical resource for all QA activities Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue Advises others on a variety of topics within own functional area Tracks internal trends and suggests process improvements based on observations Leverages the appropriate resources to provide solutions for internal/external customers Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns Identifies implications/conclusions from the logical analysis of a complex situation or issue Serves as the QA subject matter expert (SME) for internal/external regulatory compliance audits Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success Manages budget for own area, allocates resources and delegates accordingly, applying knowledge of profit drivers within own area / department Minimum requirements: Education: Bachelor of Science degree in an engineering or related field. Minimum 7 years' experience in quality, with at least 3-5 years in the medical device industry or pharmaceutical industry. Minimum 2-3 year's management experience Experience in interface with Domestic and Foreign government agencies. (managing audits, Front room experience) CAPAs and validation. Preferred requirements: Experience with SAP preferred Experience in Lean/Six Sigma preferred Computer proficiency in Microsoft Office (Word, Excel, Power Point, Project, and Outlook) Physical Demands: Must be able to lift, push/pull, and carry up to 25 pounds Must be able to wear appropriate personal protective equipment as required Position requires sitting or standing for long hours Use of hands and fingers to manipulate office and calibration equipment is required At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA TX - El Paso - Northwestern Dr.Additional LocationsWork Shift
$71k-104k yearly est. Auto-Apply 6d ago
Quality Assurance Manager
Eurofins Scientific 4.4
Lancaster, MN jobs
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Job Description The Quality Assurance Manager oversees assigned laboratories to ensure compliance with company policies and procedures, implementation of a robust and effective Quality System, and employment of continuous improvement activities. This includes identifying or developing quality management tools, assessing risks and leading root cause investigations, evaluating company-wide trends for weaknesses and opportunities to advance the company's leadership position in the environmental industry, and training quality staff in the implementation of Quality Systems, techniques, and tools. Quality Assurance Manager responsibilities include, but are not limited to, the following: * Ensure adherence to highest quality and efficiency standards in laboratory operations * Lead team, schedule, and train employees; ensure coverage and performance; foster morale and teamwork * Lead interventions in laboratories with inadequate Quality Systems or management * Review assigned laboratories' monthly reports to stay current with laboratory issues and achievements * Review audit responses for assigned laboratories as needed * Compile Quality System metrics to monitor the status and performance of assigned laboratories * Monitor laboratory certification activities to ensure no major losses of certifications * Investigate issues raised by clients, QA, sales, and other departments to find root cause, implement corrective action, and document proper response * Perform internal investigations of suspected data integrity related and/or ethics violation issues * Provide review and comments on state, client, TNI, and federal agency programs and requirements * Monitor regulatory and accreditation activities for business opportunities and threats * Research Quality Systems information and stay abreast of new practices to maintain knowledge and provide guidance * Participate in environmental industry committees or organizations to contribute to industry-wide initiatives that can impact the company * Identify and/or develop model Quality System tools, policies, and procedures, and make these available for adoption within the laboratories * Develop and participate in the Quality Management Training for new and prospective quality management staff * Coordinate quality assurance and technical training courses, as applicable * Assist Laboratory Directors/BUMAs in QA personnel decisions including: staffing, hiring, evaluations, and disciplinary actions as requested * Attend meetings to stay current with industry trends and QA programs * Participate in the Laboratory Information Management System (LIMS) oversight and standardization * Assist with internal Quality Systems Audits as needed Qualifications The ideal candidate would possess the following skills and knowledge: * Strong leadership, initiative, and teambuilding skills * Knowledge of environmental laboratory accreditation requirements * Quality Assurance and Quality Control principles * Statistics and the fundamental application in an environmental laboratory * Root cause analysis and corrective action principles * Change management techniques and group dynamics * Knowledge of environmental chemistry, regulatory methods and accreditation requirements, and instrumental techniques * Experience with laboratory operations * Strong analytical, logical, and negotiating skills * Strong interpersonal skills and leadership abilities * Ability to handle multiple priorities * Strong computer, scientific, and organizational skills * Excellent communication (oral and written) skills and attention to detail * Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude * Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Basic Minimum Qualifications: * BS degree in a science, combination of QA experience and knowledge of the environmental testing industry may substitute for a degree. * Minimum 5-10 years of environmental laboratory experience and 5 years QA experience. Advanced degree may substitute for experience. * Authorization to work in the United States indefinitely without restriction or sponsorship * Professional working proficiency in English is required, including the ability to read, write, and speak in English. Additional Information Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with additional time as needed. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
$74k-98k yearly est. 11d ago
Quality Assurance Manager-Parenteral
Nivagen Pharmaceuticals 3.7
Sacramento, CA jobs
About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Quality Assurance Manager-Parenteral (Full Time) At Nivagen as Quality Assurance manager you will be responsible for overseeing and managing all QA activities related to the manufacturing of sterile injectable (parenteral) products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement. Responsibilities: Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness. Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary. Review and approve deviations, including the associated investigation reports, and corrective/preventative actions. Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations. Review and approve sampling protocols, risk assessments, and master batch records. Author, review and approve SOPs as appropriate for both Operations and Quality. Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities. Participate in internal audits, support regulatory inspections or customer audit activities, as needed. Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance. Assist in the development or assignment of training to key stakeholders related to QMS. Contribute to the preparation of Periodic Quality Reviews. Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards. Support the implementation of a quality culture and best practices within the affiliate organization Qualifications: Education/Experience: Candidates with a Bachelor's degree must have at least 10 years of relevant experience; those with a Master's degree require 5+ years of experience. Strong background in manufacturing and quality assurance within the pharmaceutical or biotechnology industry is essential. Knowledge, Skills, and Abilities: Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards. Proactive approach and strong critical thinking skills. Must be able to work in a team environment within own team and interdepartmental teams. Excellent communication and interpersonal skills. Experience in quality administered systems. Strong organizational skills and attention to detail. Experience with regulatory compliance and documentation. Ability to mentor and review the work of other colleagues. Knowledge of electronic systems such as Compliance wire., Veeva, Track wise, SAP, LIMS, Maximo, Microsoft Office etc. Job Requirements: This role is primarily day shift, Monday - Friday, with 24/7 support of manufacturing as quality issues arise. Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements. Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments. Must be able to gown for entering controlled areas. Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.). Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs. Overtime and weekend work may be required. Individuals must be available via cell phone (on-call). Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $85,000-$95,000 per Year / $40/hr. (for hourly basis) Relocation assistance available Annual bonus Eligibility (Based on yearly company and personal performance) Medical, dental and vision coverage Paid time off plan 401k savings plan with No matching Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
$85k-95k yearly Auto-Apply 60d+ ago
Quality Assurance Manager - Materials Release
Zoetis 4.9
Lincoln, NE jobs
Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow. Benefits Include: 4 weeks accrued paid vacation and 13 paid holidays. 401(k) match with company profit sharing. Tuition reimbursement and Student Loan repayment program. Great Health, personal, and family benefits starting day 1. Position Summary The Materials Release QA Manager is responsible for QA oversight of incoming inspection, warehousing and shipping, sampling and release of raw materials, packaging and labeling components, and contracted intermediates/finished goods. This position is responsible for the direct supervision of the teams performing these functions. As needed, the Materials Release QA Manager will interface directly with customer and internal auditors, regulatory inspectors and provide guidance and support in the interpretation and enforcement of regulatory guidelines. Hours: 1st shift. Position Responsibilities Oversee and manage the incoming inspection and raw material release teams. Ensure the accurate and efficient preparation of all release documents (raw material, certificates/declarations, etc.). Ensure all materials are compliant with the registered specifications and that releases occur in timely manner. Support the quality of materials and products in a GMP environment. Create and revise material specifications. Ensure the appropriate specifications are in-place. Monitor and identify regulatory/compendial changes affecting raw material requirements. Support Periodic Product Reviews (PPRs) for Raw Materials and Packaging Components Identify and communicate metrics (e.g., release timelines); track RFT on incoming shipments. Identify and escalate areas of risk, particularly those with vendors and materials. Identify and drive to resolution areas of risk associated with vendors and materials. Support the qualification of new vendors/materials. QA oversight of the in-coming materials and outgoing finished goods warehouses. Support site project initiatives. Lead/participate in investigations and change management activities. Support regulatory agency, customer, and internal audits. Support market action activities. Maintain the department Standard Operating Procedures and compliance with the Zoetis Quality standards. Other responsibilities, as assigned. Education and Experience B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience. Technical Skills and Competencies Required Experience with label printing and/or plastic molding (preferred). Leadership and/or supervisory (preferred) experience. Knowledge of USDA, FDA, and EU regulations, with an emphasis on FDA regulations and requirements. Experience in change management processes, regulatory compliance, quality operations, manufacturing for vaccines and/or bio/pharmaceutical manufacturing operations. Demonstrated investigation, problem solving and risk assessment/management skills. Organizational skills, attention to detail. Excellent verbal and written communication skills . Works effectively in a team-based environment. Demonstrated ability to work with internal and external colleagues. Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Veeva Vault, ERP (SAP) and Laboratory Information Management (LIMS) systems. Physical Position Requirements Ability to sit, stand and walk. Some travel may be required. Occasional overtime/weekend work Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$86k-110k yearly est. Auto-Apply 60d+ ago
QA Release Sr. Manager
American Regent 4.7
New Albany, OH jobs
Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
$69k-96k yearly est. Auto-Apply 29d ago
QA Release Sr. Manager
American Regent Laboratories 4.7
New Albany, OH jobs
Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
$69k-96k yearly est. Auto-Apply 28d ago
Quality Assurance (Product) Manager
Niowave 3.5
Lansing, MI jobs
Summary/objective The Engineering and Facilities (E&F) Planning Coordinator works closely with project team members, members of the leadership team and key customers to help deliver major organizational projects and key initiatives efficiently. The E&F Planning Coordinator manages the technical and administrative tasks, such as scheduling, resource forecasting and planning, document and information distribution, report collation and communication support. The E&F Planning Coordinator, Engineering/Facilities provides direct support to the Facilities and Engineering Team. This position is integral to the successful coordination, alignment, and management between the departments/disciplines related to engineering, design, fabrication, building operations (facilities), EH&S, radiation safety and cGMP quality regulations. You are an open minded, committed team player who is able to meet people where they are and utilize communication and tools to masterfully guide them to the goal. Words used to describe you include self-starter, resilient, exhibits patience and grace. You are energized by completing tasks well and on time, enabling teams to reach optimal outcomes. You are someone who lives and breathes keeping things organized and supporting others in being successful. Essential functions Work independently and with members primarily in or related to the engineering/facilities, accelerator, EH&S, radiation safety including but not limited to project leads within the technical teams, and members in the leadership team.. Maintain portfolio of medium complexity projects supporting manufacturing and continuous improvement. Development of templates and standards for electronic project tracking and resource estimation. Masterfully manage up, down, and across the organization to optimize outcomes and proactively contribute to a fun, nurturing, motivating culture. Provide information and regular support to stakeholders. Serve as point of contact for various working groups; Share relevant documentation and reports with project teams. Develop in-depth understanding of project scope and particulars i.e. timeframes, project teams, etc. Schedule project activities for internal team and contractors. Maintain senior leadership and execution level schedules for project success. Understand formal escalation and review processes. Provide support to project managers and business leaders. Thorough project documentation; Creating and reviewing of reports. Positively influence a diverse team of skilled professionals. Within the department and across the organization, foster a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization. Competencies Excellent communication and interpersonal skills - you know how to develop & maintain strong relationships with all levels/teams of the organization. Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understand how to integrate into a new team/organization - appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understand your own communication and learning styles, assess others' styles, and are able to find the right path to connect the two. Exceptional technology skills - you find working with any software very comfortable and you easily adapt to new products; Highly efficient with MS Office products; Expert skill with project tracking such as MS Project and Smartsheet is essential. Extremely attentive to details, particularly with written communications, and PowerPoint presentations. Highly responsive and resourceful. Ability to anticipate needs and use good business judgment in escalating priority issues. Extremely confidential; experienced in handling highly sensitive information discreetly. Accountable, responsible, and able to work independently. Very flexible, able to pivot quickly as priorities change. Professional demeanor; calm, polite, kind, well-spoken. Required education and experience Bachelor's degree in engineering, business, management, or related field or equivalent combination of work experience, certifications and/or degree. 8+ years' experience supporting project teams and providing technical and administrative support to others. Preferred education and experience Formal training/experience in agile project management. Formal training/experience with Scrum and Lean project management framework and tools. Project management certification such as CAPM, PMP, PMI-ACP, or CSM. MS Office certification. Educational or work experience with manufacturing, engineering, information systems. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to: Stand; walk; sit; stand and sit for prolonged periods Use hands and fingers to handle, or feel objects, tools or controls Vision abilities including near vision/acuity and visual color discrimination Talk and hear Reach with hands and arms Climb stairs Wear safety glasses, goggles, gloves, and Tyvek suit Ability to lift or move products and supplies, up to 25 pounds. Position Type/Expected Hours of Work/Travel Full-time position. Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position is a part of shift work including nights, weekends, and holidays. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. .Other duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
$70k-100k yearly est. 60d+ ago
Quality Assurance Manager
Cosmos Corporation 4.2
Saint Peters, MO jobs
Job DescriptionDescription: At Cosmos Corporation, we make health and wellness products that help people and pets live better lives. From our O'Fallon, Missouri headquarters, we manufacture high-quality, natural liquid products with ingredients people trust. We are looking for a new ideal team player as a Quality Assurance Manager in our Quality department! The Quality Assurance Manager is responsible for maintaining Cosmos's Quality Management System and maintaining customer expectations across internal teams and external stakeholders. You will be leading and coaching a small department while managing the document control system, supporting the implementation of new products, renewing certifications, issue resolution, improving quality standards, communicating with suppliers, and other responsibilities. Develop and maintain programs related to providing safe, high-quality products. Develop and facilitate Good Manufacturing Practices (cGMP) training for managers and employees. Maintain and manage current ISO 9001:2015 standards. Familiarity with FDA Regulations, including 21 CFR 211. Maintain and continuously improve the Quality Management System. Address and resolve nonconformities and complaints, identify trends, and compliance information to managers and supervisors. Continuous review, update, and train on standard operation procedures (SOPs) and work instructions (WIs). Ownership and maintenance of Cosmos's Hazard Analysis and Critical Control Point (HACCP) Plan. Lead and perform internal and external audits and report findings to internal stakeholders at a regular cadence and provide recommendations for adjustments based on findings. Responsible for upholding customer, consumer, regulatory agency, and certification body expectations related to Cosmos' business processes and products. Provide timely insight and input through involvement with the new product development and product line extensions. Maintains the Document Control Program, including files and tracking databases. Ownership and management of Cosmos's Supplier Quality Program by tracking supplier data, performing supplier audits, collaborating with the Supply Chain Team, and participating in Vendor Reviews. Provide leadership, coaching, and support for direct reports. Lead, support, and respond to customer, regulatory, and third-party audits of the Cosmos Manufacturing Facility. Requirements: You will hold a Bachelor's Degree in food science or a related field. Preventive Controls Qualified Individual (PCQI) Certification is preferred. Five plus years of experience in the field of quality assurance, quality regulations, and implementation and experience in leading a team. Competencies Technical Capacity. Organizational Skills. Teamwork Orientation. Communication Proficiency. A Week In The Life Your work schedule will be Monday through Friday starting at 8:00 a.m. to 5:00 p.m. Weekly tasks for your role will be group huddles, leading and participating in project team meetings, oversight of document control, non-conformance processes, cross-department collaboration through several touchpoints, planning and execution of new products on the manufacturing floor, and participating in issue resolution. On Wednesdays, you will head to the lunch room at 11:40 a.m. for the Cosmos Minute, where the entire company meets at 11:45 a.m. to learn about other team members and special company announcements at Cosmos. What's In It for You Comprehensive medical, dental, and vision insurance. 401(k) with company contribution. Paid vacation, sick leave, holidays, and 5 Mission Days. Short- & long-term disability, life insurance, and supplemental coverages. Development programs. A positive, purpose-driven culture where people truly care about one another. Cosmos is a company that supports and invests in its employees. We have a healthy workplace culture guided by a clear vision, mission, promise, and values! Our culture is intentionally fostered daily by how employees live out our values. The result is a place where employees genuinely enjoy coming to work every day! Equal Opportunity Employer Cosmos Corporation is an equal-opportunity employer. We prohibit discrimination and harassment of any kind as outlined by federal, state, or local laws. Cosmos Corporation makes hiring decisions based solely on qualifications, merit, and business needs at the time.
$61k-90k yearly est. 11d ago
Manager, Quality Assurance
Hikma Pharmaceuticals 4.9
Dayton, NJ jobs
Job Title: Manager, Quality Assurance Job Type: Full-Time About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. Description: We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Assurance Manager to join our team. In this role, you will be responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, you will be responsible to direct batch record review, control and release, handle investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Key Responsibilities: * Regular and predictable onsite attendance and punctuality. * Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner. * Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches. * Places lots on HOLD if Quality issues are detected and notifies senior management. * Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner. * Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements. * Conducts routine investigation and departmental meetings to facilitate the performance of release function. * Manages personnel for in-process filling and inspection/packaging monitoring * Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise. * Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control. * Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization. * Performs QA review and approval of LIR's (Laboratory Investigation Reports). * Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. * Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments. * Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. * Assists the QA management in developing on department budget. * Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. * Manages attendance records for all direct reports. Qualifications: We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: * Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field * Preferred are beneficial [List the required qualifications such as education, skills, and experience] Preferred Qualifications: * Additional college courses in Microbiology, cGMPs, Statistics or Quality Management Skills: * Must have history of strong documentation skills and attention to detail * Familiarity with cGMPs and CFR for US and EU * Excellent organizational skills and ability to multi-task and perform work in a timely manner * Demonstrates ability to lead a department, projects and meetings effectively * Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management * General computer skills and ability to prepare presentations and address large groups * Demonstrated attention to details and accuracy * The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Compensation: Base Salary: $ ,000 to $ ,000 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer*: * Annual performance bonus, commission, and share potential * Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute * A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries * 3 personal days (prorated based on hire date) * 11 company paid holidays * Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits * Employee discount program * Wellbeing rewards program * Safety and Quality is a top organizational priority * Career advancement and growth opportunities * Tuition reimbursement * Paid maternity and parental leave * Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Recruiters: Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. Location: Dayton, NJ, US, 08810 Nearest Major Market: New Jersey
$75k-106k yearly est. Auto-Apply 11d ago
Quality Assurance Manager, Contract Manufacturers
Revance 4.2
Johnson City, TN jobs
The Quality Assurance Manager, Contract Manufacturers (CMOs) oversees all quality-related activities for external manufacturing partners producing OTC semisolid drug products. This includes compliance with FDA 21 CFR Part 210/211, CHPA guidelines, ICH Q7/Q9/Q10, supplier quality expectations, and internal QMS requirements. Reporting to: Director, Quality Services Location: Johnson City, TN - onsite Responsibilities/Essential Duties: Provide quality oversight of CMOs producing OTC semisolid products. Develop and maintain Quality Agreements. Plan and execute GMP audits; support regulatory inspections. Review batch documentation, deviations, and OOS/OOT investigations. Provide technical QA oversight for semisolid manufacturing processes. Oversee complaint investigations, CAPA management, and effectiveness checks. Evaluate and approve change controls from CMOs. Oversee stability program execution and data review. Manage supplier and material quality, including qualification, requalification, and specification control. Ensure supplier notifications, investigations, and raw material issues are managed per GMP. Support continuous improvement and QMS enhancements. Office-based with travel to CMOs and supplier sites. Ability to wear PPE as required. Basic Qualifications: Bachelor's degree & 5+ years' directly related experience. Preferred Qualifications: Bachelor's degree in scientific or engineering field. 5-10 years' QA experience in pharmaceuticals, OTC, or semisolid manufacturing. Experience managing CMOs and suppliers. Knowledge of FDA 21 CFR 210/211 and ICH Q guidelines. Technical expertise in semisolid manufacturing quality standards. Strong auditing and communication skills. Proficiency with electronic QMS platforms. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
$103k-126k yearly est. Auto-Apply 24d ago
Quality Assurance Manager
Cosmos Corporation 4.2
Missouri jobs
Requirements You will hold a Bachelor's Degree in food science or a related field. Preventive Controls Qualified Individual (PCQI) Certification is preferred. Five plus years of experience in the field of quality assurance, quality regulations, and implementation and experience in leading a team. Competencies Technical Capacity. Organizational Skills. Teamwork Orientation. Communication Proficiency. A Week In The Life Your work schedule will be Monday through Friday starting at 8:00 a.m. to 5:00 p.m. Weekly tasks for your role will be group huddles, leading and participating in project team meetings, oversight of document control, non-conformance processes, cross-department collaboration through several touchpoints, planning and execution of new products on the manufacturing floor, and participating in issue resolution. On Wednesdays, you will head to the lunch room at 11:40 a.m. for the Cosmos Minute, where the entire company meets at 11:45 a.m. to learn about other team members and special company announcements at Cosmos. What's In It for You Comprehensive medical, dental, and vision insurance. 401(k) with company contribution. Paid vacation, sick leave, holidays, and 5 Mission Days. Short- & long-term disability, life insurance, and supplemental coverages. Development programs. A positive, purpose-driven culture where people truly care about one another. Cosmos is a company that supports and invests in its employees. We have a healthy workplace culture guided by a clear vision, mission, promise, and values! Our culture is intentionally fostered daily by how employees live out our values. The result is a place where employees genuinely enjoy coming to work every day! Equal Opportunity Employer Cosmos Corporation is an equal-opportunity employer. We prohibit discrimination and harassment of any kind as outlined by federal, state, or local laws. Cosmos Corporation makes hiring decisions based solely on qualifications, merit, and business needs at the time. Salary Description $75,000-$90,000/year
$75k-90k yearly 13d ago