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Catalent · 1 month ago

Quality Assurance Specialist II, Operations - Nights

Chelsea, MA

Full-time

Onsite

Mid, Senior Level

$73K/yr - $96K/yr

5+ years exp

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and they are seeking a Quality Assurance Specialist II. This role is responsible for supporting daily operations in a GMP Manufacturing Facility, providing oversight of production activities and ensuring compliance with quality standards.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

GMP knowledgeQuality Assurance experienceMicrosoft Office SuiteMaterial Requirements PlanningQuality Management Systems

Required

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

Preferred

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

Must be proficient in Microsoft Office Suite, and experience with Material Requirements Planning (MRP) systems or Quality Management Systems (QMS) is preferred

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.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

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)

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2022 (1)