Quality Assurance Specialist II

Catalent • Chelsea, MA

1d • Onsite

About The Position

The Chelsea facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest Good Manufacturing Practices (CGMP) unit of its kind for DPI in North America.
The Quality Assurance Specialist II - Operations is responsible for supporting operations in a GMP Manufacturing Facility. This individual provides oversight of production activities with limited supervision.

Requirements

• Bachelors degree is required, preferably in a scientific discipline
• Minimum of 3-5 years of progressive experience in a GMP environment is required
• Minimum of 1 year of Quality Assurance experience in support of GMP production is required
• Working knowledge of GMPs and their application to pharmaceutical manufacturing is required
• Must have the ability to lift up to 50 pounds

Nice To Haves

• Experience in the use of Material Requirements Planning (MRP) systems is 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
• 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)
• Other duties as assigned

Benefits

• 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
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level