Master Records QA Specialist

Express Employment Professionals - Cincinnati East; Homewood (AL); On-site; USD 36,000 - 44,000; Full time

Job summary

Asteria Health is seeking a Quality Assurance Technician to support Master Batch Record issuance and review, document control, and compliance initiatives in a fast-paced 503B outsourcing facility.

The role emphasizes strong technical writing, organization, and attention to detail while ensuring adherence to cGMP and FDA requirements. You will collaborate with cross-functional teams to maintain quality systems and archival processes.

Qualifications

• Bachelor's degree preferred in science or related field.
• Minimum 2 years of practical Quality experience in an FDA-regulated environment (503B, pharmaceutical, medical device, or related).
• 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.

Responsibilities

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

Skills

Quality experience

cGMP knowledge

Technical writing

Communication

Attention to detail

Time management

Multitasking

Document control

Education

Bachelor's degree

Tools

Microsoft Office

Adobe

eQMS

Job description

Asteria Health is seeking a Quality Assurance Technician to support Master Batch Record issuance and review, document control, and compliance initiatives in a fast-paced 503B outsourcing facility.

The role emphasizes strong technical writing, organization, and attention to detail while ensuring adherence to cGMP and FDA requirements. You will collaborate with cross-functional teams to maintain quality systems and archival processes.