QA Specialist I - GMP Pharmaceutical Manufacturing

Catalent, Inc.; Chelsea (MA); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Defined career path

Diverse, inclusive culture

Competitive PTO and holidays

Health, dental, and vision benefits (1

Tuition reimbursement

Job summary

Catalent, Inc. is seeking a Quality Assurance Specialist I for our Chelsea, Massachusetts site to support GMP manufacturing operations. You will participate in investigations, CAPAs, and ensure quality compliance across production activities.

The role requires a Bachelor's in a scientific field and 1–3 years of GMP experience, with proficiency in MS Office and the ability to handle physical tasks as needed. Salary ranges and benefits are provided by Catalent.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 1–3 years of progressive experience in a GMP environment required.
• At least 1 year of Quality Assurance experience supporting GMP production.
• Working knowledge of GMPs and their application to pharmaceutical manufacturing.
• Proficiency with Microsoft Office Suite (editing content/flow diagrams).
• Must be able to lift up to 50 pounds and perform sit/stand/walk tasks.

Responsibilities

• Perform real-time review of production activities, including batch records review and area clearance.
• Support raw material sampling and coordinate with material management for release.
• Review and approve Materials Management and Supply Chain activities; manage disposition of controlled materials and work in progress.
• Support Environmental Monitoring Program sampling for the Chelsea Facility.
• Provide basic support during inspections by health authorities; initiate deviations and investigations.
• Support GMP manufacturing shifts as needed and participate in shift change and floor meetings.
• Perform other duties as assigned.

Skills

GMP knowledge

Microsoft Office

Quality Assurance experience

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

Catalent, Inc. is seeking a Quality Assurance Specialist I for our Chelsea, Massachusetts site to support GMP manufacturing operations. You will participate in investigations, CAPAs, and ensure quality compliance across production activities.

The role requires a Bachelor's in a scientific field and 1–3 years of GMP experience, with proficiency in MS Office and the ability to handle physical tasks as needed. Salary ranges and benefits are provided by Catalent.