Reports to: Quality Assurance Supervisor or Manager Responsibilities:
- Conducts Annual Drug (Product) Reviews and Device History Reviews.
- Maintains Regulatory Compliance documents and documents of external origin.
- Maintain Document Control (including Records Retention)
- Participates in internal and external audit process.
- Participates in Mock (product) recall audits.
- Maintain SOPs and Quality Forms as part of Document Control.
- Maintains records of customer-approvals documents as evidence of authenticity.
- Participate in QA Audits and draft reports of such audits.
- Effects changes to specification sheets as approved through change control requests.
- Support Change Control program and maintain evidence of product and process changes.
- Maintains SOP binders and updates such documents through approved CCs.
- Supports EWL Employee training and documentation.
- Maintains suppliers and vendors qualification program.
- Supports and maintains approvals of formulary, specifications and manufacturing records.
- Participates in Mock (product) recall audits.
- Maintains Records Retention for QA Dept.
- Initiates, Tracks, and authors Annual Drug Reviews (ADRs) for OTC and Annual Drug Reviews and Device History Reviews (DHRs).
- Assists in collating, reviewing, filing, maintaining of OTC bulk batch records, COAs, formula documents, etc.
- Tracks and Performs physical sample retain review for ADRs and DHRs.
- Tracks, Maintains, Closes requests for Change Control Notices (CC), Defective Material forms (DMF), and Deviations, Return Authorizations, Investigations, etc.
Requirements
- Minimum of 2 years of diploma program or 4-year college degree
- 2 to 3 years industry or related experience.
- Previous experience in Pharma, Cosmetics, food, medical device, or allied profession
- Good Technical Writing ability.
- Excellent knowledge of Word, Excel, Access, and other Windows-based programs
- Good record-keeping skills.
Benefits
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match