Quality Assurance Compliance Specialist (CQA) LOC : Cleveland/Akron, OH

Quality Assurance Compliance Specialist (CQA) LOC : Cleveland/Akron, OH

  • Posted on : 09-08-2023
  • Job Type : Full Time only
  • Salary : 100,000 - 200,000

Job Description:

Key Responsibilities

  • Responsible for control and archival of documentation for approved and rejected materials.
  • Tracks open CAPA plans and Change Control documents to closure.
  • Creates metrics for CAPA effectiveness evaluations and other KPIs, as needed.
  • Coordinates, participates in and/or writes investigations of product complaints.
  • Analyzes and trends data, and issues reports as required.
  • Assists in the gathering, coordination and analysis of data for Annual Product Quality Reviews.
  • Assists in the gathering, coordination and analysis of data as needed for the Plant Management Metrics Review.
  • Evaluates PU procedures to ensure compliance with FK policies and procedures, revising site documents as necessary.
  • Assists in the coordination and collection of data for all internal corporate and external audits.
  • Effectively takes notes during plant compliance meetings and inspections/audits.
Requirements

  • Bachelor of Science degree plus 3 years GMP Pharmaceutical experience or equivalent education and experience.
  • Must be able to communicate effectively both verbally and in writing with all levels of employees on all aspects of compliance.
  • Must have excellent technical writing skills.
  • Must have experience as a Technical Reviewer.


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