Quality Assurance Specialist

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.

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.

• 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

• 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

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.

• 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…