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

• Tracking and maintaining SOPs, master records, component documents and manufacturing batch records
• Issuing and distributing Packaging and Production Batch Records

Reviewing and releasing products

• Reviewing Production Batch Records for GMP compliance and ensuring reconciliation of products
• Reviewing Packaging Records for GMP compliance and ensuring reconciliation of bottled products and packaging components
• Reviewing 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 before releasing products to the Packaging and Shipping Department

Conducting investigations

• Conducting full-scale out-of-specification (OOS) and batch investigations
• Reviewing and approving raw materials/Components for release
• Qualifying equipment and vendors
• Organizing, documenting, and monitoring product stability
• Following up with necessary departments and/or personnel to resolve document-related issues
• Managing document change control
• Carrying out internal audits and facility inspections
• Retrieving and pre-reviewing manufacturing records in case of an audit

Assisting other departments

• Assisting with deviation reports, record inserts, log sheets, etc.

Maintaining training files

• Maintaining training files for all manufacturing employees and assisting with training as needed

Maintaining QA spreadsheets

• Maintaining QA spreadsheets

Interacting with colleagues

• Effectively working, interacting, and communicating with co-workers and lead/supervisors
• Demonstrating professional behavior while working in a team approach when managing challenging situations

Providing a safe, secure, and comfortable environment

• Assisting in providing a safe, secure, and comfortable environment for all staff

Performing other duties as assigned

Performs other duties as assigned