Quality Assurance Specialist I

Regulatory Toolkit; Chelsea (MA); Vor Ort; USD 70.000 - 85.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision benefits

Tuition reimbursement

Competitive PTO & 8 holidays

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP knowledge

Documentation

Flow diagrams

Physical fitness

Ausbildung

Bachelor's degree

Tools

Microsoft Office

Jobbeschreibung

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.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.