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 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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

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.
Strong organizational skills; able to prioritize and manage through complex processes/projects.
Ability to be hands-on and detail orientated.
Proficient in MS Office application suite as well GMP electronic applications such as QMS / LIMS