Temporary Worker, Associate II, QA

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 temporary staff member for Quality Assurance will primarily be responsible for supporting quality operation activities. This supporter 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. With partnership from the QA team, they will oversee the generation and revision of product-related master documents to support GMP manufacturing of drug substances and drug products. We are looking for a mature professional capable of working independently and in a team setting who continually evaluates 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 contained in this document.

• Actively participates in fostering a positive, collaborative work culture.
• Ensuring adherence to cGMPs across the organization.
• Addresses all quality and compliance matters in an open and timely manner.
• QA inspection and release of incoming controlled and critical material from the warehouse.
• Receipt, review, and process new item forms for material procurement in Veeva.
• Author and review standard operating procedures within the electronic document management system.
• Initiating Raw Material Specification form for critical received raw materials.
• Logbook creation, review, and archival.
• Document contingency management of on-the-floor documents and bimonthly maintenance of steady state documents.
• Document issuance and maintenance of routine forms for Manufacturing, Quality Control, and Microbiology.
• Maintain QA scanned documentation and document control room organization/archival
• Assist with review of Preventive maintenance, calibration, and work order documentation in the asset management software.
• Assist with approved vendor re-qualifications and managing the approved supplier list
• Assist in evaluating standard operating procedures, master batch records, and test methods for alignment with GMPs.
• Review executed records for accuracy, completeness, and adherence to internal standards and industry regulations.
• Observe and provide oversight to the manufacturing and laboratory areas, including aseptic processing areas.
• Gown aseptically for manufacturing suites and maintain qualification for aseptic gowning.
• Complete visual inspection of parenteral products. Maintain 20/20 (corrected) visual acuity.
• 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.
• Other duties as assigned.

Qualifications

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

• 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
• Exposure to 21 CFR Parts 210 & 211, 21 CFR 600, 21 CFR 820, and/or 21 CFR 1270, biotechnology, and electronic computer systems is desired
• Excellent communication skills, written and verbal.
• Team player with the ability to influence others.
• Detail-oriented, excellent written and verbal communication skills
• Effectively manages cross-functional communication
• Multitasks strategically and tactically in a fast-paced work environment.
• 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 simultaneously.

Physical Demands

• Adjusting or moving objects weighing up to 25lbs

Travel Requirements

• N/A

Location

• This is a site-based temporary position located in Research Triangle Park, NC, and it will require some non-standard working hours, including early morning, late evening, and/or weekends.

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.