Supervisor, Quality Assurance Operations

Supervisor Quality Assurance (QA) Operations

Position Summary:

• Work Schedule: Monday Friday from 8am-5pm overtime as needed depending on production
• 100% on-site (Chelsea MA)

Catalent Inc. is a leading global Contract Development and Manufacturing Organization (CDMO) and the Boston-area facility is Catalents 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 Supervisor of Quality Assurance (QA) Operations who will oversee production operations in a Good Manufacturing Practice (GMP) Facility. This individual supervises the work of QA Specialists and Senior QA Specialists on the Operations team. You will be a key member of ensuring safety for the patients using our products.

The Role:

• Oversight of production activities including area clearance issuance and review of batch records and making decisions on initiation of Discrepancies. Oversight review and approval of Materials Management and Supply Chain activities. Initiation review approval and trending of Discrepancies including Deviations and Investigations
• Oversight of Environmental Monitoring Program for Chelsea Facility including Controlled Environments and Clean Utilities. Management of metric generation and reporting on the state of control of the Controlled Environment and Clean Utilities for the Boston Manufacturing Site
• Revision and/or review and approval of SOPs Protocols Reports and Master Batch Records for continuous improvement. Management of metric generation and reporting on Quality Metrics for production-related events
• Support of implementation of CAPA and review of CAPA effectiveness as determined through Discrepancies. Support review and implementation of Change Controls
• Review and approval of Certificates of Analysis (COAs) for Raw Materials Intermediates and Finished Goods
• Disposition of controlled materials (Work in Progress Finished Product and Raw Materials). Oversee final release of the product including Certificate of Conformance and approval for Distribution of product
• Provide support during compliance inspections conducted by external sources (i.e. health authorities). An active member of a self-directed work team with operations personnel to critically evaluate and continuously improve manufacturing control systems
• All other duties as assigned

The Candidate:

• Bachelors degree in a scientific discipline is required preferably in physical science or chemistry
• A minimum of seven (7) years of progressive experience in a GMP environment is required
• A minimum of seven (7) years of Quality Assurance experience in support of GMP production is required
• Working knowledge of GMPs and their application to pharmaceutical manufacturing is required. Requires knowledge of FDA guidance documents current FDA trends and use of FDA website tools and previous exposure to investigations and product complaints is also required. Must be able to interpret applicable standards and objectively make decisions
• Must be proficient with Microsoft Office Suite and preferred experience with Materials Requirements Planning (MRP) systems
• Physical requirements: Minimal travel required. This position requires the ability to walk sit and stand. Specific vision requirements include reading of written documents.

Pay:

• The anticipated salary range for this role in Massachusetts is $89200 to $135000 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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 application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.