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Catalent · 1 day ago

Senior Specialist, Quality Operations

Princeton, NJ

Full-time

Onsite

Mid, Senior Level

$110K/yr - $125K/yr

7+ years exp

Catalent is a leading global CDMO, trusted by pharma, biotech and self-care companies to accelerate the development, manufacturing and delivery of products that improve lives. The Senior Specialist, Quality Operations provides advanced oversight and guidance for GMP Manufacturing of Cell Therapy products, leading the development and management of Quality Systems, ensuring compliance with regulations, and supporting audits and inspections.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Provide advanced QA oversight for GMP documentation, batch record review, and compliance activities

Lead development and management of Quality Systems, including change control, risk management, and supplier qualification

Support and manage investigations (OOS, deviations), CAPAs, and engineering change requests

Review and approve validation protocols, COAs/COCs, calibration, and maintenance records for completeness

Compile, track, and present quality metrics for batch release, client projects, and site compliance programs

Drive process improvements to reduce defects, improve turnaround times, and ensure timely batch disposition

Serve as dedicated QA liaison for client projects from initiation through closure, including audits and meetings

Coordinate and facilitate risk assessments, maintain site risk register, and report to leadership

Author, review, and revise SOPs; conduct internal audits; and support external audits and inspections

Train new QA staff and contribute to Management Reviews and Annual Product Reviews

Other duties as assigned

Qualification

GMP regulationsQuality Systems managementRisk ManagementBiological manufacturing processesAuditor certificationProject managementCommunication skillsProblem-solving skills

Required

Bachelor of Science degree required, preferably in a Life Sciences discipline; Master of Science degree preferred

Minimum of 7 years' experience within the biologic, biopharmaceutical, or regulated industry

Experience performing cGMP internal audits and/or supplier audits

Cross-site, inter and intra departmental project management experience and experience with electronic document management systems desired

Proficient in GMP regulations, batch record review, and batch disposition processes, with ability to apply scientific and regulatory principles to resolve operational and quality challenges

Experience with Risk Management and Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs

Proficient with biological manufacturing processes including cell banking, microbial/cell culture, fermentation, purification, and fill/finish

Strong communication skills (verbal, written, oral), proven ability to work independently and collaboratively, prioritize tasks, and apply problem-solving skills in a fast-paced GMP environment

Preferred

Auditor certification (CQA or equivalent) is a plus

Benefits

Defined career path and annual performance review and feedback process.

Diverse, inclusive culture.

Potential for career growth on an expanding team.

Cross-functional exposure to other areas within the organization.

152 hours of paid time off annually + 8 paid holidays.

Medical, dental, vision and 401K benefits effective day one of employment.

Tuition Reimbursement.

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)