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

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

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