Kincell Bio collaborates with cell therapy developers by using considerable scientific experience and industry understanding. Backed by North Carolina Biotechnology Center.
About the role
The Senior Quality Assurance Associate supports the day-to-day early phase cell and gene therapy clinical GMP manufacturing operations via execution of all operational elements of the Quality Management System (QMS), including but not limited to the EDMS (electronic document management system) and training management system in support of gene and cell therapy manufacturing production.
What they're looking for
- BS or equivalent in life science or related field and 5+ years industry experience in manufacturing/testing (GMP) and/or clinical (GCP) Quality Assurance, or equivalent combination of education and experience
- Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, gene therapy, bioanalytical testing, and clinical research
- Experience authoring, reviewing, and/or approving procedures, policies, work instructions, and any other related controlled documentation needed to support site requirements
- Experience authoring, reviewing, and/or approving quality events such as deviations and laboratory investigations/OOS/OOT
- Exceptional communication and interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges
- Exceptional oral and written communication skills to all organization levels as well as clients and vendors
More about this role
Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.
For more information, visit our website at www.kincellis.com.
The Senior Quality Assurance Associate supports the day-to-day early phase cell and gene therapy clinical GMP manufacturing operations via execution of all operational elements of the Quality Management System (QMS), including but not limited to the EDMS (electronic document management system) and training management system in support of gene and cell therapy manufacturing production. They will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, and the Laboratories to ensure cGMP...
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