Quality Assurance Specialist I

Catalent Pharma Solutions•Chelsea, MA

9d•$70,000 - $85,000•Onsite

About The Position

The Quality Assurance Specialist I supports operations at Catalent’s GMP manufacturing facility in Chelsea, Massachusetts. The role supports manufacturing investigations and corrective and preventive actions (CAPA), and helps ensure compliance and quality across production activities. The position is 100% onsite and follows a 2/2/3 work rotation from 6:00 a.m. to 6:00 p.m.

Requirements

Bachelor’s degree; preferably in a scientific discipline.
At least 1–3 years of progressive experience in a GMP environment.
At least 1 year of Quality Assurance experience supporting GMP production.
Working knowledge of Good Manufacturing Practices (GMPs) and their application to pharmaceutical manufacturing.
Proficiency in Microsoft Office Suite, including editing content and formatting and creating flow diagrams.
Ability to lift up to 50 pounds as needed.
Ability to perform work involving frequent sitting, walking, and standing, and occasional pushing, pulling, kneeling, and reaching.

Responsibilities

Perform real-time review of production activities, including area clearance and the issuance and review of batch records.
Support raw material sampling and coordinate with material management for release.
Review and approve Materials Management and Supply Chain activities.
Manage disposition of controlled raw materials and work-in-progress materials.
Support the Chelsea Facility Environmental Monitoring Program, including sampling water and other utilities.
Provide basic support during compliance inspections conducted by external sources, such as health authorities.
Initiate discrepancies, including deviations and investigations.
Support GMP manufacturing shifts as needed, including participating in shift-change and floor meetings with operators.
Perform other duties as assigned.