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.
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
- Veeva document management and vault training manager experience preferred.
- Effectively manages cross-functional communication.
- Strong organizational skills; able to prioritize and manage through complex processes/projects.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to work independently and stay on task in a fast-paced environment.
Physical Demands
- Adjusting or moving objects weighing up to 25lbs
- Must be able to become gown-qualified with participation within an ISO 7 cleanroom environment
Travel Requirements
- N/A
Location
- This is a site-based temporary position located in Gainesville, FL, and will require some non-standard working hours, including early morning or late evening.
Schedule
- Monday through Friday
- 1st Shift with occasional 2nd shift support as needed
- Occasional Weekends and Overtime Required
#LI-Onsite
Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
NOTE TO EMPLOYMENT AGENCIES: Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.
Skills Required
- BS degree or equivalent in life science or a related field, plus 5 or more years of industry experience in GMP manufacturing/testing and/or GCP Quality Assurance, or an equivalent combination of education and experience.
- Knowledge of FDA regulations and standards related to cell therapy, gene therapy, bioanalytical testing, and clinical research.
- Experience authoring, reviewing, or approving procedures, policies, work instructions, and controlled documentation.
- Experience authoring, reviewing, or approving quality events, including deviations and laboratory investigations, OOS, and OOT investigations.
- Exceptional communication and interpersonal skills, including influencing behaviors and negotiating and resolving challenges.
- Exceptional oral and written communication skills with employees at all organizational levels, clients, and vendors.
- Strong organizational skills and ability to prioritize and manage complex processes and projects.
- Ability to work hands-on with strong attention to detail.
- Proficiency with Microsoft Office and GMP electronic applications such as QMS and LIMS.
- Veeva document management and Vault Training Manager experience.
- Ability to manage cross-functional communication effectively.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to work independently and stay on task in a fast-paced environment.
- Ability to become gown-qualified and participate in an ISO 7 cleanroom environment.
- Ability to adjust or move objects weighing up to 25 pounds.
What We Do
Kincell is a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing. Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs. For more information, please visit our website at www.kincellbio.com
