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The Cell Processing Quality Control Specialist I trains and becomes competent at performing, interpreting and reporting for quality control assays required for cellular product evaluation. Responsible for the quality control (QC) of reagents, supplies, facility environmental testing, laboratory equipment maintenance and QC performed in the Cell Manipulation Core Facility. The Cell Processing Quality Control Specialist I is responsible for QC procedures that are performed under the highest standards of quality in a timely manner while minimizing costs.
Job Responsibility
Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records
Accurately perform, analyze and demonstrate proficiency of the following tests at a minimum: automated and manual cell counts, including trypan blue viability testing, basic flow cytometry analysis (CD34, T subsets, 7AAD viability, etc.), potency assays such as CFUs, etc., basic microbiology cultures and gram stains (clinical and environmental)
Must interpret QC and test results, trends and respond/report according to procedure and policy
Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and all maintenance performed
Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance
Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications
Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify the senior specialist or supervisor
Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens
If applicable, answer questions from clinicians or other lab personnel
Maintain complete records of all testing performed
Maintain general clean and organized appearance of the department
Ensure reagents/test kits have received dates, expiration dates, and if applicable, opened dates
Attend monthly department and any additional training/educational meetings
Participate in all applicable safety training sessions
Know the location and contents of the safety manual
Know the location/use of all applicable safety equipment
If needed, participate in government or regulatory agency inspections
Requirements
Associate degree in chemical, physical or biological science or medical laboratory required
Basic knowledge of general clinical laboratory practices, hematology and microbiology
Able to perform aseptic processing of samples for relevant tests
Ability to accurately perform simple laboratory math calculations
Ability to work closely with others, possess solid interpersonal and communication skills
Capable of working in a fast-paced environment
Capable of handling stress of producing accurate results under time constraints
Good judgment, problem solving and analytical skills
Requires attention to detail and interpersonal skills to effectively communicate with both laboratory and clinical staff within a complex, multi-organization environment
Entry level in for cellular product high complexity testing lab
Must qualify as Testing Personnel under CLIA as independent judgment is required for the high complexity work performed in the following areas: hematology, immunology, microbiology, and molecular biology
Experience in a clinical laboratory performing high complexity testing (may have been a part of an internship program)
Nice to have
Bachelor's degree in medical technology, clinical laboratory, chemical, physical or biological preferred
MT (ASCP) certification or International Cytometry Certification Exam (ICCE) or other laboratory certification preferred