Quality Assurance Specialist I

Catalent • Chelsea, MA

8d • Onsite

About The Position

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

The Chelsea site is a global Center of Excellence for spray dry dispersion and dry powder inhaler capsule manufacturing and packaging. It supports inhalation drug products from clinical development through commercial launch and provides services including powder processing, capsule filling, blister packaging, quality control, and analytical testing.

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 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 frequently sit, walk, and stand, and occasionally push, pull, kneel, and reach.

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’s 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 changes and floor meetings with operators.
• Perform other duties as assigned.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Potential for career growth.
• Defined career path and annual performance review and feedback process.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level