Quality Assurance Manager

Medivant Healthcare; Chandler (AZ); On-site; USD 120,000 - 150,000; Full time

Job summary

Medivant Healthcare, a manufacturer of sterile injectable medications, seeks a Manager QA– MQA to oversee documentation control, batch record review, sampling, and material releases. The role ensures cGMP compliance and supports daily quality operations across production and packaging.

The position is full-time and onsite, with responsibilities spanning line clearances, MBMR/BMR preparation, investigations, and labeling reviews. Strong QA background and MasterControl experience preferred.

Qualifications

• Bachelor’s degree in a scientific discipline as listed.
• 7–10 years in pharma QA or manufacturing QA roles.
• Knowledge of cGMP, documentation practices, sampling procedures, and material release processes.
• Strong attention to detail and organizational skills.

Responsibilities

• Upload documents into the Document Management System (DMS).
• File and archive documents with tracking records for retrieval and archival.
• Review and release incoming materials per Approved Vendor List and CoA requirements.
• Issue controlled documents and logbooks to all departments.
• Perform AQL inspections as required.
• Conduct line clearances and in-process/finished-product sampling for manufacturing and packaging.
• Prepare Master Batch Manufacturing Records (MBMRs) and review 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 for accuracy and compliance.

Skills

Attention to detail

Documentation practices

Quality assurance

Regulatory compliance

Education

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

Tools

MasterControl

Electronic documentation systems

Job description

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.