Quality Assurance Specialist II

Quality Assurance Specialist II

Position Summary:

• Work Schedule: 2/2/3 Schedule – 6pm to 6am
• 100% on-site

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.

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
• 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

The Candidate:

• 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
• Experience in the use of Material Requirements Planning (MRP) systems is preferred
• Must have the ability to lift up to 50 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 
• 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 - Let us help you finish your degree or start a new degree!

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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the