Supervisor, Quality Assurance Operations

Catalent Pharma Solutions•Chelsea, MA

3d•Onsite

About The Position

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 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 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.

Requirements

Bachelor's 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.

Nice To Haves

preferred experience with Materials Requirements Planning (MRP) systems

Responsibilities

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

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
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