Job Title: Cell Processing QC Specialist
Job Number: 24884
Responsible for performing, interpreting and reporting of 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. This position is responsible for QC procedures that are performed under the highest standards of quality in a timely manner while minimizing costs. All QC Technologists are responsible for adherence to the applicable regulations and standards (FDA (cGMP, GTP, etc), FACT, JC, etc). Must be able to work independently, accept the job specific responsibilities and demonstrate accountability for own actions and decisions. All technologists participate in on going performance improvement and quality improvement activities. Technologists are responsible to utilizes resources efficiently and effectively, takes responsibility for own learning needs, and to bring ideas and concerns to superiors.
- 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 review / 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 technologist or supervisor.
- Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
- Able to perform aseptic processing of samples for relevant tests.
- Must have working knowledge of using information systems and databases to communicate and capture results
- Must be able to accurately perform simple laboratory math calculations
- Follows Regulations (FDA, CLIA, HIPAA, OSHA, state) standards (FACT, JC) and safety guidelines.
- Capable of working in a fast-paced environment and communicate effectively in a diverse work group.
- If applicable, answer questions from clinicians or other lab personnel.
- Maintain complete records of all testing performed
- Maintains general clean and organized appearance of the department.
- Makes sure reagents/test kits have received dates, expiration dates, and if applicable opened dates.
- Reviews and trains on new procedures.
- 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.
- Perform other duties as directed by supervisor.
- Works with Supervisor to monitor daily activities and assists others in the lab on a regular basis.
- Assists Supervisor in review of records as required.
- Able to appropriately trouble shoot instrument issues and test systems. Takes the initiative to correct problems when issues/problems are identified.
- Takes the lead in implementing a new method or installation of new equipment following all of the regulatory requirements.
- As appropriate notifies clinical staff of significant findings if test systems deviate from the laboratory's established performance specifications.
- Prepares training materials and competency assessment tools under the direction of the supervisor.
- Assists the supervisor to ensure that the department is inspection ready at all times for a given area of relevant standards and regulations.
- BS in Medical Technology or related field, MT ASCP (or equivalent) strongly preferred.
- Must qualify as a General Lab Supervisor under CLIA as independent judgment is required for the high complexity work performed in the following areas; Immunohematology, hematology, microbiology and flow cytometry. Knowledge of other non-routine laboratory procedures such as CFU assays, PCR and ELISA testing is a benefit.
- Must have a minimum of 3 years experience in a laboratory setting.
- Must have working knowledge of FDA, AABB, FACT, cGMP, cGTP and state regulations regarding laboratory procedures.
- Must be able to demonstrate the ability to successfully communicate, transfer knowledge to others.
- Has demonstrated successful project management skills by managing competing tasks/projects
- Must have basic knowledge of general clinical laboratory practices, hematology, flow cytometry, immunohematology, and microbiology. In addition must demonstrate general lab skills, aseptic practices, knowledge of lab safety and infection control practices.
- Position requires an ongoing commitment to upgrading of job skills. Must be able to work closely with others & possess solid interpersonal & communication skills.
- Capable of working in a fast-paced environment; effective in a diverse work group; willing to work in a rapidly changing work unit.
- Able to work independently, capable of handling stress of producing accurate results under time constraints; willing to accommodate schedule adjustments, as well as off-shift and weekend assignments as workload dictates.
- Must possess good judgment, problem solving and analytical skills.
- The ability to be flexible & adaptable to changing technology.
- Requires attention to detail and interpersonal skills to effectively communicate with both laboratory and clinical staff within a complex, multi-organization environment.
- Teaching and advisory responsibilities requires in-depth knowledge and prior experience. This position, in addition to the above, must have good technical and teaching skills, able to make sound judgment, good problem solving and analytical skills.
- Must have demonstrated increased working knowledge in a relevant area and can become a subject matter expert for the department in that area.