Overview

The QA Senior Quality Assurance Specialist supports Quality Assurance functions focused on manufacturing operations. The position will review/audit complex documents including master batch record review, executed batch record review, CMO deviation/investigation/complaint review, QC method, stability and data review; ensure compliance to defined Quality System procedures; support of Phase 3 Clinical trials for CDX-0159, and support review and submission of BLA as well as any commercial activities. Additional responsibilities may include vendor audit support for CDX-0159 and associated audit requirements as well as standard operating procedure reviews.

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

Qualifications

• 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 
• BLA review and submission experience preferred

Compensation

The expected base salary range for this position is $115,156 to $140,852. 

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, 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, and sick days. A summary of our benefits can be found on our careers page.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.