quality assurance specialist
$145,600 - $166,400/Yr
Actalent - Andover, MA
posted about 1 month ago
Full-time - Mid Level
Andover, MA
Administrative and Support Services
About the position
The Quality Assurance Specialist role at Actalent involves ensuring compliance with FDA and ICH regulations through batch record review and documentation approval. This position supports investigations and prepares for inspection readiness, contributing to the overall quality assurance processes within a cGMP environment.
Responsibilities
- Responsible for batch record review.
- Assess CMO batch compliance with FDA and ICH regulations.
- Support investigations and deviations.
- Review and approve documents including CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations, and OOS in support of product release.
- Support and prepare for inspection readiness.
Requirements
- BS/MS in Biology discipline.
- 4+ years of experience in a cGMP environment.
- Strong knowledge of FDA, EU, ATMP, and JP regulations.
Benefits
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
