Quality Assurance Specialist I
Catalent’s Chelsea, Massachusetts site—often referred to as the Boston location—is a global Center of Excellence for spray dry dispersion (SDD) and dry powder inhaler (DPI) capsule manufacturing and packaging, supporting inhalation drug products from clinical development through commercial launch. Located at 190 Everett Avenue, the approximately 96,000‑square‑foot GMP facility features ISO 8 production suites, high‑potency containment capabilities, and advanced spray drying equipment, including multiple large‑scale GMP spray dryers. The site offers integrated services such as powder processing, capsule filling, blister packaging, and on‑site quality control and analytical testing, with capacity to produce up to 100 million capsules annually. Strategically positioned just minutes from Boston Logan International Airport and within the Greater Boston life sciences hub, the Chelsea site plays a critical role in Catalent’s global inhalation network and regulatory‑compliant manufacturing operations.
Position Summary
We have an opportunity for a Quality Assurance Specialist I to join our team supporting operations in a GMP Manufacturing Facility. This role provides support for Manufacturing Investigations and Corrective and Preventive Actions (CAPA). The position plays a key part in ensuring compliance and quality across production activities, contributing to the success of our manufacturing operations.
Shift: 2/2/3 Work Rotation, 6:00am to 6:00pm
Location: Chelsea, MA
100% Onsite
The Role
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
The Candidate
Minimum Requirements
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
Pay
The anticipated salary range for this position in MA is $70,000 – $85,000. Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi‑state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive paid time off plus 8 paid holidays
Community engagement and green initiatives
Medical, dental, and vision benefits effective day one of employment
Tuition reimbursement
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