QA Document Control Clerk

- 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