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Lead QA Compliance Specialist

2 months 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 are committed to fostering a community through care and collaboration. Our reputation is built on delivering innovative, results-driven business and technology solutions that empower organizations to achieve their strategic goals. We prioritize a positive work environment where learning and growth are encouraged, and we strive to make a meaningful impact on the communities we serve.

Since our inception in 2002, we have specialized in technology staffing and managed services across the United States, with a focus 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) issues, as well as product quality complaints. This role will ensure 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 closure of Stage II OOS and OOT investigations.
  • Engage 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 protocols.
  • 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 quality 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, and provide training for effective usage.

QUALIFICATIONS

  • 6 - 8 years of relevant experience in a pharmaceutical manufacturing setting.
  • In-depth knowledge of cGMPs and GLPs.
  • Proficient in TrackWise for managing electronic Quality Management System data.
  • Strong understanding of instrumental and wet analytical chemistry.
  • Knowledgeable in 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.

The candidate must be eligible to work for a US-based company without requiring visa sponsorship.

COMPENSATION AND BENEFITS

  • Competitive salary range of $100,000 to $120,000, commensurate with experience and qualifications.
  • Bonus potential of 10%.
  • Three weeks of paid vacation.
  • 401(k) matching program.