New

Quality Assurance Specialist

Children's Hospital of Philadelphia
$56,890.00 - $71,110.00 Annually
United States, Pennsylvania, Philadelphia
Jan 16, 2026
SHIFT: Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career. CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview The Clinical Vector Core (CVC) is a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) at the Children's Hospital of Philadelphia. The CCMT fosters a multidisciplinary approach to develop cures for debilitating and life-threatening genetic disorders using innovative gene and cell therapy approaches. CVC operations include manufacturing, quality control testing, and certification of recombinant adeno-associated and lentiviral viral vectors for use as Investigational Drugs in pre-clinical and early-phase clinical studies. CVC operations comply with FDA's current Good Manufacturing Practice regulations and other regulatory standards and guidelines applicable to early-phase Investigational Drugs. Vectors are made available to clinical programs in academia, industry and government in the U.S. and abroad. --- This role participates in the day-to-day operations of the Clinical Vector Core facility, with a primary responsibility to perform routine QA and Document Control functions in support of the viral vector manufacturing process under current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP), including technical review of records for clarity, correctness and compliance with SOPs, drafting policies and procedures, and assisting in planning, processing and initiating incidents reports and deviations, corrective and preventative actions and change control, and batch production record review, as described under job responsibilities. This team member plays a vital role in the CVC and helps assure that non-clinical and clinical grade viral vector manufacturing complies with cGMP standards. All employees are responsible for compliance with written policies and procedures and for correctness, truthfulness, timeliness, legibility, integrity, and accuracy when recording data and observations in compliance with current cGMP regulations. What you will do Performs routine QA functions including but not limited to material control, shipping and tracking of drug products and biological materials Performs technical review of records for clarity, correctness, and compliance with relevant SOPs Drafts policies and procedures Reviews policies and procedure Assist in planning, processing and investigating deviations Initiates incident reports and planned deviations Plans and participates in corrective and preventative actions and change implementation Reviews batch production records Participates in hosting client and regulatory audits Performs other duties as assigned Education Qualifications Bachelor's Degree Required Master's Degree Pharmaceutical, biological or chemical sciences Preferred Experience Qualifications At least one (1) year quality assurance experience. Required At least three (3) years quality assurance experience Preferred At least three (3) years in cGMP/GLP (or other regulated) environment. Preferred Skills and Abilities Demonstrated ability to prioritize work, strong organizational and documentation skills and initiative to improve processes. Change agent demeanor. Must be a flexible thinker, with an ability to quickly adapt to a rapidly changing environment. Team-oriented, self-starting individual with good communication skills. To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more. EEO / VEVRAA Federal Contractor \| Tobacco Statement SALARY RANGE: $56,890.00 - $71,110.00 Annually Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. ------------------- At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.