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