QA Specialist I — GMP Manufacturing Compliance (Onsite)

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

Benefits offered by this job

Career path and annual performance/re‑

Inclusive culture

Career growth on expanding team

PTO and 8 holidays

Community involvement and green initia

Benefits from day one (medical, dental

Tuition reimbursement

Job summary

Catalent’s Chelsea, Massachusetts site is a GMP manufacturing facility focused on spray dry dispersion and DPI capsule manufacturing. We seek a Quality Assurance Specialist I to support CAPA, investigations, and compliance across production activities.

The role involves real‑time batch review, materials management coordination, and environmental monitoring support, with a 2/2/3 shift schedule in Chelsea, MA. 100% onsite and strong GMP knowledge are essential.

Qualifications

• Bachelor’s degree is required, preferably in a scientific discipline
• Minimum of 1–3 years of progressive experience in a GMP environment required
• Minimum of 1 year of Quality Assurance experience in support of GMP production required
• Working knowledge of Good Manufacturing Practices (GMPs) and their application to pharmaceutical manufacturing is required
• Proficiency in Microsoft Office Suite, including the ability to edit content and formatting and create flow diagrams
• Role requires frequent sitting, walking, and standing; Occasionally pushing, pulling, kneeling, and reaching; Must have the ability to lift up to 50 pounds as needed

Responsibilities

• Perform real-time review of production activities, including area clearance, 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 Environmental Monitoring Program for the Chelsea Facility, including water and other utilities sampling
• 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 participation in shift change and floor meetings with operators
• Perform all other duties as assigned

Skills

GMP knowledge

Microsoft Office

Quality assurance

Education

Bachelor’s degree (science preferred)

Tools

Microsoft Office Suite

Job description

Catalent’s Chelsea, Massachusetts site is a GMP manufacturing facility focused on spray dry dispersion and DPI capsule manufacturing. We seek a Quality Assurance Specialist I to support CAPA, investigations, and compliance across production activities.

The role involves real‑time batch review, materials management coordination, and environmental monitoring support, with a 2/2/3 shift schedule in Chelsea, MA. 100% onsite and strong GMP knowledge are essential.