Quality Assurance Technician

Express Employment Professionals; Birmingham (AL); On-site; USD 54,000 - 70,000; Full time

Job summary

Asteria Health is seeking a Quality Assurance Technician to support QA activities with a focus on Master Batch Records (MBRs) issuance and review, document control, and compliance with cGMP and FDA requirements. This role helps ensure quality in a 503B outsourcing facility.

The ideal candidate has a science background, 2+ years in QA in an FDA-regulated setting, strong technical writing, and proficiency with MS Office, Adobe, eQMS, SharePoint, and document management systems.

Qualifications

• Bachelor’s degree in science or related discipline preferred.
• Minimum 2 years QA in an FDA-regulated environment (503B, pharma, or medical devices).
• Knowledge of cGMP guidelines and quality system requirements.
• Strong technical writing skills; able to draft, edit, review controlled documents.
• Excellent verbal and written communication; highly organized and detail-oriented.
• Proficiency in Microsoft Office, Adobe, eQMS, and document/inventory systems.
• Ability to work independently and in a fast-paced, small-team environment.

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 in SharePoint.
• Manage the Document Control Room for storage and retrieval.
• Assist with annual Iron Mountain archival projects.

Skills

Quality assurance

Technical writing

Communication

Attention to detail

Time management

Multitasking

Collaboration

Education

Bachelor’s degree preferred (science or related discipline)

Tools

Microsoft Office

Adobe

eQMS

SharePoint

Document management

Inventory management

Job description

The Quality Assurance Technician is responsible for supporting Quality Assurance activities with a primary focus on Master Batch Record (MBR) issuance and review. This role also contributes to document control and compliance initiatives, helping ensure adherence to cGMP and FDA regulatory requirements. Strong technical writing, organizational skills, and attention to detail are essential. The QA Technician will play a key role in supporting Asteria Health’s mission of maintaining the highest quality standards in a 503B outsourcing facility.

Essential Duties and Responsibilities

• Perform issuance of 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 and Experience Required

• Bachelor’s degree preferred (science or related discipline).
• Minimum 2 years of practical Quality experience in an FDA-regulated environment (503B, pharmaceutical, medical device, or related industry preferred).
• Knowledge of cGMP guidelines and quality system requirements.
• Strong technical writing skills and ability to draft, edit, and review controlled documents.
• Excellent verbal and written communication skills.
• Strong attention to detail with proven organizational skills.
• Proficiency in Microsoft Office, Adobe, eQMS, and document/inventory management systems.
• Ability to work independently and collaboratively in a fast-paced, small-team environment.
• Strong time management skills with the ability to multitask and meet deadlines.