Associate II, Quality Assurance

Kincell Bio, LLC•Gainesville, FL

3d•Onsite

About The Position

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. Kincell is seeking a highly motivated Associate II who will be a key contributor to a dynamic and collaborative Quality Assurance team. Quality Assurance Associate II will primarily be responsible for supporting quality operation activities. This highly motivated member of the Quality Unit will promote a culture of compliance throughout the organization by reviewing all production-related documents and assisting with quality oversight of quality events. The Associate II oversees the generation and revision of product-related master documents to support GMP manufacturing of drug substances and drug products. Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance with applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to prioritize based on criticality effectively.

Requirements

HS Diploma With 7+ years of relevant industry experience
Bachelor’s degree preferred in life sciences with 2+ Years of relevant industry experience
Prefer experience with FDA Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) in the pharmaceutical, biologic, medical device, or human tissue industries in a Document Control position, including the revision, issuance, and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc. Microsoft Word and Microsoft Excel experience
An equivalent combination of education and experience may be
Exposure to 21 CFR Parts 210 & 211, 21 CFR 820, and/or 21 CFR 1270, biotechnology, and electronic computer systems is desired
Excellent communication skills, written and
Team player with the ability to influence
Detail-oriented, excellent written and verbal communication skills
Effectively manages cross-functional communication
Multitasks strategically and tactically in a fast-paced work
Strong organizational skills; able to prioritize and manage complex processes/projects.
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to function in a rapidly changing environment and balance multiple priorities

Nice To Haves

Prefer experience with FDA Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) in the pharmaceutical, biologic, medical device, or human tissue industries in a Document Control position, including the revision, issuance, and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc. Microsoft Word and Microsoft Excel experience
Exposure to 21 CFR Parts 210 & 211, 21 CFR 820, and/or 21 CFR 1270, biotechnology, and electronic computer systems is desired

Responsibilities

Actively participates in fostering a positive, collaborative work
Ensuring adherence to cGMPs across the
Addresses all quality and compliance matters in an open and timely
Evaluating standard operating procedures, master batch records, and test methods for alignment with GMPs.
Performs review of all product-related documents such as production batch records, testing forms, logbooks, etc.
Supports raw material and finish product release
Supports deviation, CAPA, and change control
Will work directly with all departments and across sites to review and track executed documents to meet timelines. Provide status updates and reminders when necessary.
Maintains databases used for tracking various lot disposition
Support regulatory (FDA, EMA) and client audits/inspections.
Other duties as