Manager - Quality Assurance (MQA)
Job Description
About Medivant Healthcare
Medivant Healthcare manufactures high‑quality sterile injectable medications at its FDA‑inspected facilities. The company is committed to strong quality systems, regulatory compliance, and delivering safe and effective products.
Position Summary
The Manager QA– MQA supports documentation control, batch record review, sampling activities, material releases, investigations, and manufacturing quality oversight. This role ensures compliance with cGMP requirements and supports daily quality operations across production and packaging.
Key Responsibilities
• 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.
Qualifications
Required:
• Bachelor’s degree in Pharmacy, Biotechnology, Chemistry, or related scientific discipline.
• 7-10 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.
Preferred:
• Experience in sterile manufacturing or injectable facilities.
• Experience with MasterControl or similar electronic documentation systems.
• Familiarity with batch record review and AQL inspection processes.
Work Environment & Physical Requirements
• 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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