Assistant Manager - Quality Assurance (MQA)
Tailstorm Health Inc•Chandler, AZ
•$80,000 - $90,000•Onsite
About The Position
Medivant Healthcare manufactures sterile injectable medications at FDA-inspected facilities and emphasizes quality systems, regulatory compliance, and safe, effective products. The Assistant Manager - Quality Assurance supports documentation control, batch record review, sampling activities, material releases, investigations, and manufacturing quality oversight. The role helps ensure cGMP compliance and supports daily quality operations across production and packaging.
Requirements
- Bachelor’s degree in Pharmacy, Biotechnology, Chemistry, or a 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.
Nice To Haves
- Experience in sterile manufacturing or injectable facilities.
- Experience with MasterControl or similar electronic documentation systems.
- Familiarity with batch record review and AQL inspection processes.
Responsibilities
- Upload documents into the Document Management System (DMS), such as MasterControl or an equivalent system.
- File and archive documents and maintain tracking records for timely retrieval and archival.
- Review and release incoming materials according to 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 related documentation.
- Review label printing activities for accuracy and compliance.
- Perform additional duties assigned by the Department Head or designee.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
