Quality Assurance Specialist
About The Position
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.
Requirements
- Bachelor's Degree Required
- At least one (1) year quality assurance experience.
- 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.
Nice To Haves
- Master's Degree Pharmaceutical, biological or chemical sciences Preferred
- At least three (3) years quality assurance experience Preferred
- At least three (3) years in cGMP/GLP (or other regulated) environment. Preferred
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
