Catalent · 4 hours ago
Supervisor, Quality Assurance Operations
Chelsea, MA
Full-time
Onsite
Senior Level
$89K/yr - $135K/yr
7+ years expCatalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and they are seeking a Supervisor of Quality Assurance (QA) Operations. This role involves overseeing production operations in a GMP facility, supervising QA Specialists, and ensuring compliance with safety and quality standards.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
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
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
Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
Company data provided by crunchbase