QA Document Control Clerk

Overall responsibility: This position is responsible for tracking, maintaining, and archiving all GMP documentation in compliance with FDA regulatory requirements as well as company procedures and policies.

• Ensuring effective management of SOPs, master records, component documents and manufacturing batch records
• Issuing and distributing Packaging and Production Batch Records
• Reviewing and approving:
  • Production Batch Records for GMP compliance and ensuring reconciliation of products
  • Packaging Records for GMP compliance and ensuring reconciliation of bottled products and packaging components
  • Lab test results and creating Certificates of Analysis for finished products to be released to the Packaging Department
  • Approving labels, lot numbers and expiration dates
• Releasing products to the Packaging and Shipping Department
• Conducting full scale out of specification (OOS) and batch investigations
• Responsible for:
  • Reviewing and approving raw materials/components for release
  • Equipment and vendor qualifications
  • Organizing, documenting and monitoring product stability
  • Following up with the necessary departments and/or personnel to resolve document related issues
  • Document change control
  • Internal audits and facility inspections
  • Retrieving and pre-reviewing manufacturing records in the event of an audit
• Assisting other departments with documentation related functions such as deviation reports, record inserts, log sheets, etc.
• Maintaining training files for all manufacturing employees and assisting with training as needed
• Maintaining QA spreadsheets
• Effectively working, interacting and communicating with co-workers and lead/supervisor
• Demonstrating professional behavior while working in a team approach when managing challenging situations
• Assisting in providing a safe, secure and comfortable environment for all staff
• Performs other duties as assigned