QA Document Control Clerk

Job Description

Job Description

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

· 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