Celldex · 4 days ago
Senior Quality Assurance Specialist
Hampton, NJ, US
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $141K/yr
10+ years expCelldex is a company focused on supporting Quality Assurance functions in manufacturing operations. The Senior Quality Assurance Specialist will review and audit complex documents, ensure compliance with Quality System procedures, and support clinical trials and commercial activities.
BiotechnologyHealth CareOncologyPharmaceutical
Responsibilities
Assist in execution of Quality systems to support CMO manufacturing and lot release, GXP auditing and training
Review and approve master and executed batch
Observe CMO activities to support implementation of best practices and
Review method and process reports for compliance
Administer, review, follow-up and approve internal/external Deviations, Change Controls and CAPAs (Corrective and Preventive Action)
Write, review, and approve SOPs
Trend and report Quality systems related information (Deviations, CAPA, )
Conduct audits (External, Internal, Vendors, Suppliers, Sub-Contractors, Testing Facilities)
Prepare routine updates and project status report of Quality Assurance
Travel to CMO sites
Product Disposition
Assist departments with investigations related to manufactured
Qualification
Required
Bachelor of Science degree in Chemistry/Biology or related discipline
Minimum 10+ years QA experience in Biotech/Pharma industry at GMP
Experience in commercial and clinical GMP production and ability to provide QA support for both
Strong understanding of QC test methods, stability procedures and environmental monitoring programs
Strong compliance knowledge of GMP Quality Systems, policies, and regulations
Strong working knowledge of CFRs and ICH guidelines
Strong understanding of Biopharmaceutical Manufacturing Operations (Cell Culture and Purification)
Internal/external auditing experience
External manufacturing experience
Preferred
BLA review and submission experience
Benefits
Annual discretionary bonus
Long term incentive
401(K) plan with employer contribution
Health care and other insurance benefits (for employee and family)
Paid holidays
Vacation
Sick days
Company
Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.54B2024-02-29Post Ipo Equity· $460.5M
2023-11-07Post Ipo Equity· $200.5M
2021-07-12Post Ipo Equity· $287.5M
Leadership Team
A
Anthony Marucci
President & CEO
Ronald A. Pepin
Senior Vice President and Chief Business Officer
Recent News
2025-11-16
Company data provided by crunchbase