Lead Quality Assurance Compliance Specialist
2 weeks ago
SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)
Location: Billerica, MA (Onsite)
Position ID: 22911
At Wimmer Solutions, we prioritize community and collaboration. Our commitment to excellence has established us as a leader in delivering innovative business and technology solutions that empower organizations to achieve their strategic goals. We foster a positive work environment where learning and growth are encouraged, and we actively contribute to the communities we serve through meaningful partnerships with nonprofits.
Since our inception in 2002, we have specialized in technology staffing and managed services across the United States, focusing on building strong relationships with our clients and candidates to ensure mutual success.
We are currently seeking a Senior Associate, QA Compliance (APQR) to provide scientific expertise in the investigation and resolution of Out of Specification (OOS) and Out of Trend (OOT) cases, as well as product quality complaints. This role is crucial in ensuring adherence to Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Management System standards. The successful candidate will compile monthly quality metrics for internal and corporate review and analyze trends to implement corrective and preventive actions.
KEY RESPONSIBILITIES
- Collaborate with various departments to ensure timely documentation and resolution of Stage II OOS and OOT investigations.
- Engage in technical investigations related to product quality complaints.
- Provide clear verbal and written communication to customers regarding product quality inquiries.
- Draft and update standard operating procedures (SOPs) and testing methods as necessary.
- Participate in quality investigations and risk assessments, reviewing documents and processes.
- Conduct statistical analyses of critical attributes and trends in Quality Management System events for each commercial product, providing scientific rationale for conclusions in the APQR.
- Prepare the Annual Product Quality Review (APQR) report for each commercial product according to established timelines.
- Compile and present quality metrics at monthly meetings, identifying trends and compliance risks, and recommending process improvements.
- Manage the electronic Quality Management System (TrackWise).
- Implement electronic Quality Systems such as eQMS, EDMS, and LMS, providing necessary training for effective usage.
QUALIFICATIONS
- 6 to 8 years of relevant experience in a pharmaceutical manufacturing setting.
- Proficient understanding of cGMPs and GLPs.
- Extensive knowledge of TrackWise for managing electronic Quality Management System data.
- Strong background in instrumental and wet analytical chemistry.
- Solid understanding of microbiological testing.
- Proficient in MS Office applications.
- Familiarity with SAP, EDMS, LMS, and Master Control is preferred.
- Experience in the manufacture and testing of radiopharmaceuticals is highly desirable.
Must be eligible to work for a US-based company without requiring visa sponsorship.
COMPENSATION AND BENEFITS
- Salary range: $100,000 to $120,000, commensurate with experience and qualifications, as well as market considerations.
- Bonus potential: 10%
- Paid vacation: 3 weeks
- 401(k) matching available
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