Quality Control Analyst III

New York Blood Center Enterprises•Rye, NY

53d•$55 - $62

About The Position

The Quality Control Analyst III is 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. This includes performing analytical testing under Current Good Manufacturing Practices (cGMP) production of a cell therapy product, immunologic monitoring of test samples, research, and development. The primary responsibilities of this role focus on manufacturing; secondary responsibilities may include clinical research and development and program organization activities. 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). Adherence to the 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. Flexibility and dedication: Availability to participate outside of, and in addition to, normal work hours as required, including some nighttime hours during clinical processing and some weekend coverage. 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.

Requirements

Education: B.S. or M.S. in Biology, Immunology, or closely related field of science.
Experience: Minimum of 5 years of relevant laboratory experience with a B.S. or 3 years with an M.S.
Knowledge: Good understanding of hematology and immunology concepts.
Understanding of GTP, GMP, GLP, OSHA (including biosafety), FACT, and FDA regulations.
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.
Skills: 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.
Abilities: Ability to work some irregular hours, including evenings or weekends, depending on workload.
Ability to work “off-standard hours” and “on-call” hours as related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime.
Demonstrate the ability to apply good aseptic technique and uphold appropriate cleanroom behavior where applicable.
Demonstrate the ability to be certified in gowning technique for ISO 7 classified cleanroom and ISO 5 BSC where applicable.
Ability to perform data analysis, trending, and generate reports as required.
Ability to strive in a fast-paced, creative, and goal-oriented environment.
Ability to handle confidential information and maintain confidentiality.

Nice To Haves

Experience in flow cytometry, PCR, cell culturing, cell processing, blood banking, or transfusion service (preferred).
Prior knowledge of cell therapy processing of whole blood, apheresis, and other cellular products beneficial.

Responsibilities

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).
Adherence to the 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.
Flexibility and dedication: Availability to participate outside of, and in addition to, normal work hours as required, including some nighttime hours during clinical processing and some weekend coverage.
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.