GMP QA Specialist I - Onsite Chelsea, MA

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

Benefits offered by this job

Medical, dental, vision benefits

Tuition reimbursement

Competitive PTO & 8 holidays

Job summary

Catalent's Chelsea, Massachusetts site is a global Center of Excellence for spray dry dispersion and DPI capsule manufacturing, providing integrated services from powder processing to on-site quality control. The QA Specialist I will support manufacturing investigations, CAPA, and compliance across production activities in a 6:00am–6:00pm, onsite role.

The position emphasizes GMP knowledge, QA experience, and the ability to work in a fast-paced environment with cross-functional teams to ensure

Qualifications

• Bachelor's degree required; preferably in a scientific discipline.
• Minimum of 1–3 years of progressive experience in a GMP environment.
• Minimum of 1 year of Quality Assurance experience in support of GMP production.
• Working knowledge of GMPs and their application to pharmaceutical manufacturing.
• Proficiency in Microsoft Office Suite, including editing content/formatting and creating flow diagrams.
• Role requires sitting, walking, standing; must lift up to 50 pounds as needed.

Responsibilities

• Real-time review of production activities: area clearance, batch records issuance/review.
• Support raw material sampling and coordinate with material management for release.
• Review/approve Materials Management and Supply Chain activities; manage disposition of materials.
• Support Environmental Monitoring Program: water and utilities sampling.
• Provide basic support during inspections; initiate discrepancies and investigations.
• Support GMP manufacturing shifts, including participation in shift change and floor meetings.

Skills

GMP knowledge

Documentation

Flow diagrams

Physical fitness

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Catalent's Chelsea, Massachusetts site is a global Center of Excellence for spray dry dispersion and DPI capsule manufacturing, providing integrated services from powder processing to on-site quality control. The QA Specialist I will support manufacturing investigations, CAPA, and compliance across production activities in a 6:00am–6:00pm, onsite role.

The position emphasizes GMP knowledge, QA experience, and the ability to work in a fast-paced environment with cross-functional teams to ensure