Quality Assurance Specialist I

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

Benefits offered by this job

Medical, dental, and vision benefits

8 paid holidays

Tuition reimbursement

Job summary

Catalent’s Chelsea, Massachusetts site is a global Center of Excellence for spray dry dispersion and DPI capsule manufacturing. The Quality Assurance Specialist I will support Manufacturing Investigations and CAPA, ensuring compliance and quality across production activities in a 100% onsite GMP facility.

Responsibilities include real-time review of batch records, materials management support, environmental monitoring participation, and assistance during inspections.

Qualifications

• Bachelor’s degree in a scientific field required.
• 1–3 years of progressive GMP experience required.
• 1 year of Quality Assurance experience in GMP production preferred.
• Working knowledge of GMPs and their application to pharma manufacturing.
• Proficiency in Microsoft Office Suite for editing content, formatting, and diagrams.
• Physical ability to sit, walk, stand, and lift up to 50 lbs as needed.

Responsibilities

• Perform real-time review of production activities, including area clearance, issuance, and batch record review.
• Support raw material sampling and coordinate with material management for release.
• Review and approve Materials Management and Supply Chain activities; manage disposition of materials.
• Support Environmental Monitoring Program at the Chelsea Facility, including sampling.

Skills

GMP knowledge

Quality Assurance

Documentation & record keeping

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

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

Catalent offers rewarding opportunities to further your career!

Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.