• 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 paid 100% by the company

• 401K after 6 months