Quality Assurance Specialist I
Quality Assurance Specialist I
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
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
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!
Volunteer Work Disclosure
Massachusetts Lie Detector Test Notice
Not included in the source posting: about the role, what you'll do.
Who can apply
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