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Kincellis Advanced Therapies
Gainesville, FL
Source: Kincellis Advanced Therapies careers · View original posting
From Kincellis Advanced Therapies's posting. “We” and “our” refer to the employer.
Kincell Bio engineers cells into therapies
. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch.
Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.
For more information, please visit our website at www.kincellbio.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 compliance and establish a quality culture. This is a unique opportunity to help build and grow the Quality Assurance organization in a dynamic new environment. Experience with administrative access using Veeva as a document control and training management system preferred.
Essential Duties and Responsibilities
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
Essential Duties and Responsibilities
Assist in executing QA responsibilities to support material and product release.
Work with Quality team members to develop, implement, and maintain a phase appropriate Quality Management System (QMS) through the creation, review, and approval of documentation including policies and standard operating procedures (SOPs). Primary focus will be on cGXP operations.
Partner with Manufacturing and Quality Control to review/edit documentation such as batch records, methods, validation protocols and reports, and testing data.
Support the continuous improvement and oversight of Quality Management System procedures.
Assist with company-wide understanding and adopting GMP / GDP practices in alignment with established procedures.
Actively participates in fostering a positive, collaborative work culture.
Support other QA functions with other projects and tasks, where applicable.
Other duties as assigned.
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