Quality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy)

University of Pennsylvania • Philadelphia, PA

455d • $43,919 - $85,000

About The Position

The Quality Assurance Specialist (Regulatory) at the University of Pennsylvania's Center for Cellular Immunotherapy will play a vital role in ensuring the quality and compliance of investigational cell and gene therapy products. This position involves reviewing manufacturing records and product release documentation, ensuring adherence to regulatory standards, and facilitating communication across teams to support clinical trials in immunotherapy.

Requirements

• Bachelor of Science degree and 3 to 5 years of experience in a relevant field.
• Experience in a GLP/GCP/GMP setting, with direct experience in a Quality role preferred.
• Excellent verbal and written communication skills.
• Detail-oriented with strong organizational skills.
• Knowledge of manufacturing biologics products and cell and gene therapy principles.

Nice To Haves

• Master's degree in a related field.
• Working knowledge of FACT Common Standards for Cellular Therapy.

Responsibilities

• Review manufacturing batch records and product release documentation under tight deadlines.
• Verify calculations, chain of custody, and compliance with GDP, cGMP, and internal SOPs.
• Communicate errors and deviations identified during batch record review.
• Coordinate with cross-functional teams to ensure timely QA review and resolution of errors.
• Issue verified chain of custody labels and prepare release paperwork for human administration.
• Conduct receipt verification of apheresis products and coordinate with collection sites.
• Anticipate potential roadblocks affecting product release and alert management accordingly.
• Closeout the EBR ensuring all quality documents are up-to-date.
• Assist with master batch record issuance and external audits as needed.
• Train new QA Associates as required.

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
• Tuition assistance for employees and their dependents.
• Generous retirement plans with various investment options.
• Substantial time away from work for personal needs.
• Long-term care insurance options available.
• Wellness and work-life resources to support health and balance.
• Professional and personal development resources.
• Access to university resources and cultural activities.
• Discounts and special services for faculty and staff.
• Flexible work hours and options for work-life balance.
• Adoption assistance for eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Educational Services
• Education Level: Bachelor's degree