Master Batch Records QA Specialist

Express Employment Professionals; Birmingham (AL); On-site; USD 54,000 - 76,000; Full time

Job summary

Express Employment Professionals is seeking a Quality Assurance Technician to support QA activities with a focus on Master Batch Record issuance and review. You will contribute to document control and compliance efforts to ensure adherence to cGMP and FDA requirements in a 503B outsourcing facility.

The role demands strong technical writing, organizational skills, and high attention to detail, enabling you to help maintain the highest quality standards in a fast-paced, team-oriented environment.

Qualifications

• Bachelor’s degree in science or related field preferred.
• Minimum 2 years of QA experience in an FDA-regulated environment (503B, pharma or medical device preferred).
• Knowledge of cGMP guidelines and quality system requirements.
• Strong technical writing skills with ability to draft, edit and review controlled documents.
• Excellent verbal and written communication skills with strong attention to detail.

Responsibilities

• Issue Master Batch Records (MBRs).
• Assist with initial MBR review for accuracy and compliance.
• Support Change Control processes as needed.
• Scan, file, and maintain QA documents within SharePoint.
• Manage the Document Control Room to ensure proper storage, retrieval, and organization.
• Assist with annual Iron Mountain archival projects.

Skills

Technical writing

Communication

Attention to detail

Time management

Education

Bachelor’s degree preferred

Tools

Microsoft Office

Adobe

eQMS

SharePoint

Document management systems

Job description

Express Employment Professionals is seeking a Quality Assurance Technician to support QA activities with a focus on Master Batch Record issuance and review. You will contribute to document control and compliance efforts to ensure adherence to cGMP and FDA requirements in a 503B outsourcing facility.

The role demands strong technical writing, organizational skills, and high attention to detail, enabling you to help maintain the highest quality standards in a fast-paced, team-oriented environment.