Quality Assurance Technician

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.