Senior QA Compliance Specialist

2 weeks ago


Billerica, Massachusetts, United States Wimmer Solutions Full time

SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)

Location: Billerica, MA (Onsite)

At Wimmer Solutions, we prioritize community and collaboration. Our commitment to delivering innovative business and technology solutions has established us as a trusted partner for organizations striving 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.

Our organization has been providing technology staffing and managed services since 2002, focusing on building meaningful relationships with our clients and candidates to ensure mutual success.

We are seeking a Senior Associate, QA Compliance (APQR) who will play a crucial role in providing scientific expertise for root cause analysis and resolution of Out of Specification (OOS) investigations, Out of Trend (OOT) investigations, and product quality complaints. This position ensures 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, root cause analysis, and quality assurance closure of Stage II OOS and OOT investigations.
  • Engage directly in technical investigations related to product quality complaints.
  • Provide comprehensive verbal and written responses to customers regarding product quality inquiries.
  • Draft and revise standard operating procedures (SOPs) and testing methods as necessary.
  • Participate in quality investigations and risk assessments, reviewing documents, processes, and testing.
  • Conduct statistical analysis of critical attributes and trend Quality Management System events for each commercial product, providing scientific rationale for conclusions in the APQR.
  • Prepare Annual Product Quality Review (APQR) reports for each commercial product according to established timelines.
  • Compile and present quality metrics at monthly quality meetings, identifying trends, quality risks, and compliance issues, and making recommendations for process improvements.
  • Manage the electronic Quality Management System (TrackWise).
  • Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, and provide training for effective usage by employees.

QUALIFICATIONS

  • 6 to 8 years of relevant experience in a pharmaceutical manufacturing setting.
  • Proficient understanding of cGMPs and GLPs.
  • Strong expertise in Trackwise for managing electronic Quality Management System data.
  • Solid knowledge of instrumental and wet analytical chemistry.
  • In-depth understanding of microbiology testing.
  • Proficient in MS Office software.
  • 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, based on experience and qualifications.
  • 10% bonus potential.
  • Three weeks of paid vacation.
  • 401(k) matching program.


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