Lead 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)

Position ID: 22911

At Wimmer Solutions, we prioritize the connection between care and community. 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 collaboration thrive, and we actively contribute to the communities we serve through meaningful partnerships with dedicated volunteers and nonprofit organizations.

Since our inception in 2002, we have specialized in technology staffing and managed services across the greater Seattle area and the United States. Our approach centers on building strong relationships with our clients and candidates, ensuring mutual success.

We are currently seeking a Senior Associate, QA Compliance (APQR) to provide scientific expertise in conducting root cause analyses and resolving out-of-specification (OOS) investigations, out-of-trend (OOT) investigations, and product quality complaints. This role is crucial in maintaining compliance with 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 to address adverse trends.

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 and complaints.
  • Draft and revise standard operating procedures (SOPs) and testing methods as necessary.
  • Participate in quality investigations and risk assessments, reviewing documents, processes, and testing as required.
  • Conduct statistical analyses of critical attributes and trend quality management system events for each commercial product, providing scientific rationale for conclusions presented 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, creating materials to identify trends, quality and compliance risks, and recommending process, procedure, and training changes as needed.
  • Oversee the electronic Quality Management System (TrackWise).
  • Implement electronic quality systems, such as eQMS, EDMS, and LMS, providing procedures and training for effective use by employees.

QUALIFICATIONS

  • Minimum of 6 to 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 (eQMS) data.
  • Strong background in instrumental and wet analytical chemistry.
  • Solid understanding of microbiology testing.
  • Proficient in MS Office software.
  • Familiarity with SAP, EDMS, LMS, Master Control, etc., is preferred.
  • Experience in the manufacture and testing of radiopharmaceuticals is highly desirable.

Candidate 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, as well as market and business considerations.
  • +10% bonus opportunity
  • Three weeks of paid vacation
  • 401(k) matching program

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