Quality Assurance Specialist II, Operations - Nights

Quality Assurance Specialist II, Operations (Night shift, on-site)

Position Summary:

• Work Schedule: Night shift 7-day rotating 12-hour shift with hours between 6pm-6am, 2-2-3-2 schedule, often referred to Pitman schedule. This shift offers 15% differential pay
• 100% on-site (Chelsea, MA)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and the Boston-area 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 CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Quality Assurance (QA) Specialist II. The Quality Assurance Specialist II is responsible for supporting daily operations in a GMP (Good Manufacturing Practices) Manufacturing Facility. This individual provides oversight of production activities with limited supervision.

The Role:

• 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
• All other duties as assigned

The Candidate:

• 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
• 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
• Previous exposure to investigations and product complaints preferred
• Must be proficient in Microsoft Office Suite, and experience with Material Requirements Planning (MRP) systems or Quality Management Systems (QMS) is preferred
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds

Pay:

• The anticipated salary range for this role in Massachusetts is $72,781 to $96,069 annually. 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 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories