Kincell Bio, LLC
Biologic
QualityAssuranceAssociateII,ContingentWorker
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Assurance Associate II, Contingent Worker at Kincell Bio, LLC. Skills: Quality Assurance, cGMP, Document Control. Supporting quality operation activities. Reviewing all production-related documents”
What You'll Achieve.
Promote a culture of compliance throughout the organization; Ensure compliance with applicable regulatory requirements and standards; Meet client deadlines; Ensure adherence to cGMPs across the
Industry & Context.
Define problems, collect data, establish facts, and draw valid conclusions
Adjusting or moving objects weighing up to 25lbs, Some non-standard working hours, including early morning or late evening
What They're Looking For.
Must Have
HS Diploma With 7+ years of relevant industry experience, Ability to produce results in a fast-paced environment to meet client deadlines, Ability to prioritize based on criticality effectively, Ability to define problems, collect data, establish facts, and draw valid conclusions, Ability to function in a rapidly changing environment and balance multiple priorities, Microsoft Word and Microsoft Excel experience
Nice to Have
Bachelor’s degree preferred in life sciences with 2+ Years of relevant industry experience, 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., Exposure to 21 CFR Parts 210, Able to prioritize and manage complex processes/projects
What You'll Do.
Supporting quality operation activities
Reviewing all production-related documents
Assisting with quality oversight of quality events
Overseeing the generation and revision of product-related master documents to support GMP manufacturing of drug substances and drug products
Evaluating standard operating procedures
and test methods for alignment with GMPs
Performing review of all product-related documents such as production batch records
Supporting raw material and finish product release
Working directly with all departments and across sites to review and track executed documents to meet timelines
Providing status updates and reminders when necessary
Maintaining databases used for tracking various lot disposition
Supporting regulatory (FDA
EMA) and client audits/inspections
How You'll Work.
Team & Collaboration
Actively participates in fostering a positive, collaborative work; Will work directly with all departments and across sites
Communication Scope
Open and timely communication
Process & Methodology
Manage complex processes/projects
Full Job Description
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 contingent staff member for Quality Assurance 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. Essential Duties and Responsibilities Reasonable accommodations 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 conta
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