Lead QA Manager - Sterile Injectable Pharma

Medivant Healthcare; Chandler (AZ); On-site; USD 80,000 - 90,000; Full time

Job summary

Medivant Healthcare seeks an Assistant Manager - Quality Assurance (MQA) in Chandler, AZ to lead QA activities ensuring cGMP compliance across production and packaging. The role focuses on document control, batch record review, material releases, and investigations to support daily quality operations.

The ideal candidate has a PharmD/related science background with 7–10 years in pharmaceutical QA or manufacturing QA, including familiarity with MasterControl and electronic documentation systems.

Qualifications

• 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.
• Experience in sterile manufacturing or injectable facilities (preferred).
• Experience with MasterControl or similar electronic documentation systems (preferred).
• Familiarity with batch record review and AQL inspection processes (preferred).

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.

Skills

Attention to detail

Documentation accuracy

Organizational skills

cGMP knowledge

Education

Bachelor’s degree in Pharmacy, Biotechnology, Chemistry, or related scientific discipline

Tools

MasterControl

Job description

Medivant Healthcare seeks an Assistant Manager - Quality Assurance (MQA) in Chandler, AZ to lead QA activities ensuring cGMP compliance across production and packaging. The role focuses on document control, batch record review, material releases, and investigations to support daily quality operations.

The ideal candidate has a PharmD/related science background with 7–10 years in pharmaceutical QA or manufacturing QA, including familiarity with MasterControl and electronic documentation systems.