Catalent · 10 hours ago
Lead Specialist, Client QA
Harmans, MD
Full-time
Onsite
Mid, Senior Level
$120K/yr - $150K/yr
4+ years expCatalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life-changing therapies. The Lead Specialist, QA is responsible for providing QA lead support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide dedicated QA support for client projects and client interactions, serving as the primary QA contact throughout the project lifecycle
Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product
Support clinical and commercial QA activities from process development through non-clinical and commercial production
Track and present key quality metrics for client projects, including batch release timelines and deviation trends
Collaborate with clients during initial and subsequent manufacturing campaigns to ensure compliance and quality standards
Review and approve master batch records during technology transfer for client processes
Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs)
Perform risk assessments and mitigation strategies using tools such as FMEA
Maintain and update systems and databases for tracking manufacturing and quality activities
Support audits and inspections by regulatory agencies and clients and assist with internal GMP audits
Other duties as assigned
Qualification
Required
Masters' degree in a Scientific, Engineering or Biotech field with a minimum of 4 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry OR
Bachelor's degree in a Scientific, Engineering or Biotech field with a minimum of 6 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry
Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish
Familiarity with electronic systems, including developing and producing reports using Microsoft products
Creative individual with strong analytical, troubleshooting, and decision-making skills to resolve complex issues effectively
Ability to quickly learn new and novel manufacturing processes supporting new clients
Proven ability to work independently and in cross-functional teams, delivering high-quality results in a fast-paced, deadline-driven environment while meeting client and regulatory requirements
Preferred
LIMS, Master Control and Trackwise knowledge preferred
Benefits
Medical, Dental, Vision, and 401K are all offered from day one of employment.
152 hours of PTO and 8 paid holidays.
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
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