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2017-01-18 15:09:16
Key Responsibilities
Key Skills:
Quality Assurance Compliance Specialist (CQA) LOC : Cleveland/Akron, OH
2017-01-18 15:09:16
Job Type:
Full Time only
Budget $: 100,000 - 200,000
Budget $: 100,000 - 200,000
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.
- 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.
Key Skills:
