Performs essential job duties of the Quality Control Laboratory while providing guidance and expertise for the laboratory to meet the needs of customers, in accordance with accepted standards and regulations.
Adhere to CLIA requirements, current food manufacturing practices (cGMP) guidelines, and other applicable regulatory requirements.
Must demonstrate and uphold Standards of Excellence.
Maintain department records, reports and statistical data as required.
Draft new and revise existing documents: procedures, forms, etc.
Participate in proficiency testing as assigned.
May assist in the review of test results, reports and/or quality control records.
Participate in process validations and qualifications of equipment.
Enhance professional growth and development of self and staff.
Attend internal and external meetings as required, and participate on committees as requested.
Perform other duties as assigned.
Essential Job Duties:
Perform platelet production as needed
Performs donor and product QC evaluations
Perform product labeling and quarantine/dispositions of products
Investigate and review non-conformances through quality incident reporting
Perform supervisory reviews and tasks as needed
Perform controlled document writing and revisions
Receive / Review, Upload and Commit IDM test results
Provide support for the donor notification/look-back process
General laboratory equipment including but not limited to: hematology cell counters, residual cell counters, bacterial detection analyzers, pH meter, centrifuges, heat sealers, sterile docking devices, refrigerators,/freezers, sterility incubators, tubing strippers, weights, scales, balances, expressors if applicable in the lab department.
BECS (Blood Establishment Computer Systems)
Knowledge, Skills & Abilities:
Understanding of technical aspects of lab department, blood banking concepts, hematology, microbiology, serology and flowcytometry.
Must be detail-oriented, well organized, self-motivated and capable of independent work.
Experience: Laboratory experience preferred but not required.
MT (ASCP)cm or equivalent experience
CA Clinical Laboratory Scientist License (CLS) or
CA Clinical Immunohematologist Scientist License (CIS)