Quality Assurance Associate - MQA

RXinsider LTD.; Phoenix (AZ); On-site; USD 60,000 - 75,000; Full time

Job summary

Medivant Healthcare is seeking an Associate / Senior Associate - MQA to support documentation control, batch record review, sampling, and material releases. The role ensures compliance with cGMP and supports daily quality operations across production and packaging.

The candidate will perform document uploads, material release reviews, line clearances, and investigations, contributing to quality oversight in sterile injectable manufacturing environments.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 1-2 years in pharmaceutical 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 MasterControl or equivalent).
• File and archive documents with tracking records for retrieval.
• Review and release incoming materials per Approved Vendor List and COA requirements.
• Issue controlled documents and logbooks to departments.
• Perform AQL inspections as required.
• Conduct line clearances, in-process sampling, and finished-product sampling.
• Prepare Master Batch Manufacturing Records and review Batch Manufacturing Records.
• 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.

Skills

Attention to detail

Documentation

cGMP knowledge

Quality assurance

Lab skills

Education

Bachelor's degree in Pharmacy Biotechnology Chemistry

Tools

MasterControl

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 Associate / Senior Associate - 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.


• 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.

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.