Quality Control Analyst III

New York Blood Center Inc • City of Rye, NY

96d • $54 - $61

About The Position

Founded in 1964, New York Blood Center (NYBC) has served the tri-state area for more than 60 years, delivering 500,000 lifesaving blood products annually to 150+ hospitals, EMS and healthcare partners. NYBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBC serves as a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.

Requirements

• B.S. or M.S. in Biology, Immunology, or closely related field of science.
• Minimum of 5 years of relevant laboratory experience with a B.S. or 3 years with an M.S.
• Experience in flow cytometry, PCR, cell culturing, cell processing, blood banking, or transfusion service (preferred).
• Good understanding of hematology and immunology concepts.
• Understanding of GTP, GMP, GLP, OSHA (including biosafety), FACT, and FDA regulations.
• Prior knowledge of cell therapy processing of whole blood, apheresis, and other cellular products beneficial.
• Proficiency with technical skills, analytical skills, and solutions-oriented approach to problem-solving.
• General laboratory skills and knowledge of laboratory safety, including universal precautions and sterile/aseptic technique.
• Must be able to access, navigate and work in a cGMP laboratory environment.

Nice To Haves

• Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.
• Excellent verbal and written communication skills.
• Proficiency in computer systems and Microsoft Office suite.
• Must be able to access, navigate and work in a GTP, GMP, and/or GLP laboratory and/or cleanroom environment.
• Maintain accurate and detailed documentation according to regulatory guidelines.
• Periodically present results and summarize progress to team members.

Responsibilities

• Responsible for day-to-day Quality Control (QC) and analytical testing related to the conduct of Phase I, II, and III clinical trials for cell and gene therapies.
• Perform analytical testing under Current Good Manufacturing Practices (cGMP) production of a cell therapy product, immunologic monitoring of test samples, research, and development.
• Organize the QC laboratory in preparation for testing, ensuring all materials and equipment required for testing are available and ready for use.
• Perform analytical tests including flow cytometry, PCR, endotoxin, sterility, cell counts, potency and other assays related to the quality control of a cell therapy product.
• Perform daily calibration, maintenance, and routine cleaning of laboratory equipment.
• Perform work in accordance with Batch Production Records and approved Standard Operating Procedures (SOPs).
• Adhere to applicable regulations and standards, including FDA, NYSDOH, AABB, and FACT as applicable.
• Act as a subject matter expert (SME) for general equipment and/or analytical test methods.
• Prepare and revise SOPs and, with guidance, prepare protocols and reports for equipment qualifications, analytical test method qualifications and validations.
• Participate in clinical research and development.
• Conduct data analysis and prepare reports, working under general supervision.
• Participate in training involving QC analytical procedures and approved SOPs.
• Participate in program organization activities such as equipment maintenance, inventory management, ordering of supplies, and facility monitoring and maintenance.
• Recognize, monitor and evaluate technical, quality, equipment, physical conditions or problems.
• Participate in Continuing Education activities. Completes hours required by governmental agencies and/or accreditation organizations.
• Perform related duties as assigned.

Benefits

• For applicants who will perform this position in New York City or Westchester County, the proposed hiring rate is $54.61p/hr. to $61.54p/hr.
• For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant’s skills, job-related knowledge, and experience.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees