Supervisor – CCS Quality Control

New York Blood Center Inc•City of Rye, NY

8d•$125,000 - $135,000

About The Position

The Quality Control Supervisor coordinates and supervises daily product quality-control and environmental testing activities related to cell therapy manufacturing in a GMP- and GTP-compliant facility. The role primarily oversees analytical and/or microbial testing that supports aseptically processed cell therapy products, and provides technical leadership, daily oversight, and subject matter expertise in GXP-based testing. This position does not perform or supervise CLIA- or NYS CLEP-regulated testing. The supervisor provides scientific expertise and leadership to support appropriate microbial controls, regulatory compliance, product dispositions, investigations, risk analyses, and mitigations related to aseptic processing and testing. The role also leads out-of-specification investigations and process improvement efforts; trains and mentors staff; supports method transfers, qualifications, validations, and product stability programs; and helps maintain regulatory and accreditation compliance. The position requires effective collaboration with internal and cross-functional teams, accurate documentation, and continuing education. Some irregular, evening, weekend, nighttime, on-call, or overtime hours may be required depending on workload and clinical trials. New York Blood Center (NYBC), founded in 1964, serves the tri-state area and is part of New York Blood Center Enterprises (NYBCe), which provides blood products, cellular therapies, specialty pharmacy, and medical services. NYBCe is an equal employment opportunity employer.

Requirements

Bachelor’s or higher degree in biology, chemistry, clinical laboratory technology, or physical sciences, or equivalent education, training, and experience supplying the necessary knowledge, skills, and experience.
With a bachelor’s degree, at least four years of pertinent laboratory experience; with a master’s degree in a chemical, physical, or biological science, at least two years of pertinent laboratory experience.
Detailed understanding of scientific principles and theories used in quality control of analytical and microbial testing.
Knowledge of GTP, GMP, OSHA including biosafety, FACT, and FDA regulations.
Knowledge of hematology analysis, flow cytometry, PCR, potency assays, endotoxin, colony-forming-unit assays, microscopy, Gram stain, sterility, and environmental monitoring.
Experience or knowledge working in a regulated cGMP environment.
Experience or knowledge in equipment qualification, software validation, and analytical method transfer, verification, and validation.
Cultural competency and ability to communicate effectively and sensitively with diverse individuals and groups.
Excellent verbal and written communication skills.
Proficiency with computer systems and Microsoft Office.
Ability to access, navigate, and work in a GTP, GMP, and/or cleanroom environment.
Ability to plan, organize, and execute protocols under minimal supervision while following cGMP guidelines.
Ability to maintain accurate, detailed documentation in accordance with regulatory guidelines.
Ability to periodically present results and summarize progress to team members.
Ability to work irregular hours, including evenings or weekends, depending on workload.
Ability to work off-standard and on-call hours related to clinical trials, including some nighttime hours during manufacturing; overtime may be required.
Ability to apply good aseptic technique and uphold appropriate cleanroom behavior where applicable.
Ability to become certified in gowning technique for an ISO 7 classified cleanroom and ISO 5 BSC where applicable.
Ability to perform data analysis and trending and generate reports.
Ability to thrive in a fast-paced, creative, goal-oriented environment and manage multiple projects simultaneously.
Ability to handle confidential information and maintain confidentiality.

Responsibilities

Coordinate and supervise daily product QC and environmental testing activities related to cell therapy manufacturing.
Provide analytical and/or microbiological expertise, leadership, and guidance to ensure appropriate microbial controls and regulatory compliance.
Support product dispositions, investigations, risk analyses, and mitigations related to aseptic processing and testing.
Lead investigations into out-of-specification test results, corrective actions, and verification of effectiveness.
Collaborate on developing and implementing process improvement strategies.
Train, supervise, and mentor personnel conducting analytical and/or microbial testing.
Coordinate and maintain proficiency testing with the Medical Lab Director for relevant QC testing.
Support regulatory and accreditation compliance, including FDA, NYSDOH, AABB, and FACT requirements as applicable.
Oversee technical transfer, qualification, and validation of QC analytical test methods.
Support product stability programs, including stability protocols, testing, and reports.
Review and audit documentation to confirm processes follow standard operating procedures.
Develop, review, and/or approve procedures, forms, protocols, and reports supporting manufacturing and testing.
Review and maintain adequate supply inventory.
Establish positive working relationships with internal and cross-functional teams.
Participate in continuing education and complete hours required by governmental agencies and/or accreditation organizations.
Ensure appropriate use of laboratory reagents, equipment, and other resources.
Assist in evaluating new technologies, assays, and clinical research protocols.
Assist with data analysis and preparation of reports.
Keep individual and staff training requirements up to date.
Perform other related duties as assigned.