Job Title

Conducts Annual Drug (Product) Reviews and Device History ReviewsMaintains Regulatory Compliance documents and documents of external originMaintain Document Control (including Records Retention)Participates in internal and external audit process. Participates in Mock (product) recall auditsMaintain SOPs and Quality Forms as part of Document ControlMaintains records of customer-approvals documents as evidence of authenticityParticipate in QA Audits and draft reports of such audits. Effects changes to specification sheets as approved through change control requestsSupport Change Control program and maintain evidence of product and process changesMaintains SOP binders and updates such documents through approved CCsSupports EWL Employee training and documentationMaintains suppliers and vendors qualification programSupports and maintains approvals of formulary, specifications and manufacturing recordsParticipates in Mock (product) recall auditsMaintains Records Retention for QA DeptInitiates, 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, etcTracks and Performs physical sample retain review for ADRs and DHRsTracks, Maintains, Closes requests for Change Control Notices (CC), Defective Material forms (DMF), and Deviations, Return Authorizations, Investigations, etcRequirementsMinimum of 2 years of diploma program or 4-year college degree2 to 3 years industry or related experiencePrevious experience in Pharma, Cosmetics, food, medical device, or allied professionGood Technical Writing abilityExcellent knowledge of Word, Excel, Access, and other Windows-based programsGood record-keeping skillsBenefitsMedical, Dental, and Vision InsuranceLife Insurance paid 100% by the company401K after 6 months