QA Master Batch Records Specialist - cGMP & Documentation

Express Employment; Alabama; Vor Ort; USD 52.000 - 76.000; Vollzeit

Zusammenfassung

Express Employment is seeking a Quality Assurance Technician to support Master Batch Record issuance and review in a fast-paced FDA-regulated environment. You will help maintain cGMP compliance, manage controlled documents, and contribute to document control initiatives at a 503B outsourcing facility.

The role requires strong technical writing, attention to detail, and the ability to work independently or with a small team.

Qualifikationen

• Bachelor's degree preferred in 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 with 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

cGMP

FDA Regulations

Technical Writing

Document Control

SharePoint

Microsoft Office

eQMS

Attention to Detail

Time Management

Teamwork

Ausbildung

Bachelor's degree preferred

Tools

SharePoint

Microsoft Office

Adobe

eQMS

Jobbeschreibung

Express Employment is seeking a Quality Assurance Technician to support Master Batch Record issuance and review in a fast-paced FDA-regulated environment. You will help maintain cGMP compliance, manage controlled documents, and contribute to document control initiatives at a 503B outsourcing facility.

The role requires strong technical writing, attention to detail, and the ability to work independently or with a small team.