Compliance Quality Assurance Manager
4 days ago
Job Summary:
The Accuro Group is seeking a highly skilled Compliance Quality Assurance Manager to join their team in Marietta, PA. This role will provide quality system compliance for Technical Services by managing quality system workload, including leading investigations and developing corrective actions.
Key Responsibilities:
- Perform root cause analysis, facilitating cross-functional teams to investigate deviations and determine robust corrective actions
- Support timely completion of TS quality system action plans, including writing, revising, or coordinating change controls, SOPs, audits, and training documentation
- Represent the TS department at site change control meetings and prepare and track change controls to make improvements outside of deviations
- Develop and revise TS SOPs to align with global requirements and requests, tracking and trending progress of CAPAs (EHS and GMP) using a routine reporting system
- Interact and coordinate with personnel from manufacturing, Supply Chain, TS, QA/QC, regulatory, etc., and communicate immediately with QA, Operations, Supply Chain, and EHS management for all TS discrepancies that impact product quality or safety
- Develop internal GMP and EHS audit schedules on a yearly basis and interact with external regulatory authorities as needed during routine and non-routine audits
Requirements:
- B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy
- 3+ years of pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role
- Working knowledge of pharmaceutical facilities, equipment, and systems, including a technical understanding of industry and science practices related to the business
- Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations and compliance
- Demonstrated problem-solving and investigational skills
Estimated Salary Range: $65,000 - $85,000 per year, based on location and experience. If you are a motivated professional looking to advance your career in compliance quality assurance, please submit your application.
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