Quality Assurance Specialist II, Operations - Nights

Catalent•Chelsea, MA

19d•Onsite

About The Position

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.

Requirements

High School Diploma/GED is required with at least five (5) 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
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

Nice To Haves

Bachelor’s degree in a scientific discipline is preferred with a minimum of three (3) years of progressive experience in a GMP environment
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
All other duties as assigned

Benefits

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
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.