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.Minimum 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 paid 100% by the company.401K after 6 months.
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