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The Quality Assurance Specialist reports to the Cell Therapy QA Director and Technical (or Laboratory) Director. They serve as a primary resource for the developemnt and maintenance of Quality Assutance Programs, testing of procedures, special projects, investigations/analysis and reporting in assigned ares. The specialist directs the work of assigned personnel in the assessment of QA data, collects, summarizes and evaluates quality contraol data, investigates problems and recomments solutions, and assists in development, revision and/or monitoring of laboratory procedures and quality assurance programs, including proficiency testing and regulartory compliance.
Shift: Day
Requirements
- Bachelors degree in Medical Technology or equivalent science
- A minimum of five (5) years of general clinical laboratory experience required, with one (1) year of Cell Therapy or Transfusion Medicine experience preferred
- American Society of Clinical Pathology (ASCP) certification
Knowledge
- High-level knowledge of Cell Therapy technical procedures and instrumentation.
- Proper assessment and evaluation techniques are necessary to analyze externally manufactured cell therapy procedural manuals and integrate the relevant content into existing operations.
- In addition to familiarity with quality control procedures and policies, requires knowledge of regulatory requirements (including but not limited to FACT, FDA CFR Title 21, and Joint Commission
- High level of analytical ability and laboratory insight is required to determine Quality Assurance indicators, target values, and goals for the laboratory.
- Thorough comprehension of Quality Control practices is necessary to function as a Technical Consultant.
- Knowledge of word processing and spreadsheets is required, as well as knowledge of related QA programs.
- Understanding of laboratory processing and externally manufactured cell therapy drug product procedures
Salary Range: Minimum $31.92/hour - Maximum $52.69/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility.
In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.
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