Catalent, Inc. is looking for a Quality Assurance Specialist II to support daily operations in a GMP Manufacturing Facility, ensuring product quality and compliance with regulatory standards.
Requirements
- Minimum of one (1) year of Quality Assurance experience in support of GMP production required
- Working knowledge of GMPs and their application to pharmaceutical manufacturing is required.
- Must be able to interpret applicable standards and objectively make decisions with the support of management
- Must be proficient in Microsoft Office Suite
- experience with Material Requirements Planning (MRP) systems or Quality Management Systems (QMS) is preferred
- Previous exposure to investigations and product complaints preferred
Responsibilities
- Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of discrepancies
- Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities
- Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
- Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement. Initiation of Discrepancies, including Deviations and Investigations. Support of implementation of CAPA as determined through Discrepancies
- Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods. Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
- Provide basic support during compliance inspections conducted by external sources (i.e. health authorities). Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
Other
- High School Diploma/GED is required with at least five (5) years of progressive experience in a GMP environment
- Bachelor’s degree in a scientific discipline is preferred with a minimum of three (3) years of progressive experience in a GMP environment
- This position has a 7-day rotating 12-hour shift with hours between 6am-6pm, although overtime may be required depending on production needs. This shift is a 2-2-3-2 schedule, often referred to Pitman schedule.
- Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds
