Quality Assurance Associate I
Primary Responsibilities:
- Review and release of raw materials. Ensuring that all materials are reviewed and released within the required time frame. Request deviations are needed.
- Track and disposition materials past re-evaluation dates.
- Review and track all temperature chart recorders. Request deviations as needed.
- Review and disposition cleaning verification batch records and testing packages.
- Perform room and equipment clearances per procedure following cleaning conducted by production.
- Maintain a full understanding of all AmbioPharm SOPs and policies along with all cGMP, CFR, ICH guidances that are applicable to the manufacturing of APIs.
- Issues re-packaging paperwork and performs review and approval when returned. Tracks the documentation through the process.
- Issues labels as requested.
- Perform weekly housekeeping tours.
- Works cross-functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
- Other assignments as needed within the scope of QA Associate training curriculum. These assignments may be distributed among the QA I Associates.
- Enforcement of GMP Compliance.
- Promotes teamwork and good communication.