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
- 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
- reviewing and approving raw materials/Components for release
- equipment and vendor qualifications
- organizing, documenting and monitor product stability
- following-up with the necessary departments and/ or personnel to resolve document related issues
- 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
