Title: Quality Assurance Associate Reports to: Quality Assurance Supervisor or Manager Department: Quality 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