Quality Assurance Associate - MQA
- Upload documents into the Document Management System (DMS – MasterControl or equivalent).
- File and archive documents while maintaining tracking records for timely retrieval and archival.
- Review and release incoming materials in accordance with the Approved Vendor List and Certificate of Analysis requirements.
- Issue controlled documents and logbooks to all departments.
- Perform AQL inspections as required.
- Conduct line clearances, in‑process sampling, and finished‑product sampling for manufacturing and packaging operations.
- Prepare Master Batch Manufacturing Records (MBMRs) and review executed Batch Manufacturing Records (BMRs).
- Pull, label, and store product samples after manufacturing.
- Support product and material destruction processes.
- Participate in failure investigations and support documentation.
- Review label printing activities for accuracy and compliance.
- Perform any additional duties assigned by the Department Head or designee.
- Bachelor’s degree in Pharmacy, Biotechnology, Chemistry, or related scientific discipline.
- 1-2 years of experience in pharmaceutical QA or manufacturing quality assurance roles.
- Knowledge of cGMP, documentation practices, sampling procedures, and material release processes.
- Strong attention to detail, documentation accuracy, and organizational skills.
- Experience in sterile manufacturing or injectable facilities.
- Experience with MasterControl or similar electronic documentation systems.
- Familiarity with batch record review and AQL inspection processes.
- Full‑time onsite role requiring presence in production and packaging areas.
- May require extended standing, gowning, and movement between controlled environments.
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