- Ensuring effective management of SOPs, master records, component documents and manufacturing batch records - Issuing and distributing Packaging and Production Batch Records - Reviewing · 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 monitor 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 |