Quality Assurance Specialist I

Quality Assurance Specialist ICatalent'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 SummaryWe 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% OnsiteThe RolePerform real-time review of production activities, including area clearance, issuance, and review of batch recordsSupport raw material sampling and coordinate with material management for releaseReview and approve Materials Management and Supply Chain activities; Manage disposition of controlled raw materials and work in progress materialsSupport the Environmental Monitoring Program for the Chelsea Facility, including water and other utilities samplingProvide basic support during compliance inspections conducted by external sources such as health authorities; Initiate discrepancies, including deviations and investigationsSupport GMP manufacturing shifts as needed, including participation in shift change and floor meetings with operatorsPerform all other duties as assignedThe CandidateMinimum RequirementsBachelor's degree is required, preferably in a scientific disciplineMinimum of 1–3 years of progressive experience in a GMP environment requiredMinimum of 1 year of Quality Assurance experience in support of GMP production requiredWorking knowledge of Good Manufacturing Practices (GMPs) and their application to pharmaceutical manufacturing is requiredProficiency in Microsoft Office Suite, including the ability to edit content and formatting and create flow diagramsRole requires frequent sitting, walking, and standing; Occasionally pushing, pulling, kneeling, and reaching; Must have the ability to lift up to 50 pounds as neededPayThe 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 CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent 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.