Performs essential job duties of the Quality Control Laboratory while providing guidance and expertise for the laboratory to meet the needs of SDBB customers, in accordance with accepted standards and regulations. This role will support the SDBB safety, GMP and Quality Plan.
Adhere to CLIA requirements, current food manufacturing practices (cGMP) guidelines, and other applicable regulatory requirements.
Must demonstrate and uphold SDBB 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.
Performs red cell blood grouping and antibody identification on donor and referred patient blood samples
Determines suitability for transfusion of donor units with discrepant ABO or Rh groups and unexpected red cell antibodies
Performs pre-transfusion compatibility testing
Performs molecular procedures and platelet compatibility work
Provides verbal and written reports, technical assistance and consultation to customers
Assists in maintaining file of HLA typed apheresis donors and performs computer searches when requested
Quality Control Laboratory Essential Job Duties:
Performs platelet production as needed
Performs donor and product QC evaluations
Performs product labeling and quarantine/disposition of products
Investigates and review non-conformances through quality incident reporting
Performs supervisory reviews and tasks as needed
Performs validations and new process development
Performs controlled document writing and revisions
Receives / Reviews, Uploads and Commits IDM test results
Provides support for the donor notification/look-back process
Component Production Laboratory Essential Job Duties:
Currently does not staff MT I positions
Normal laboratory environment with biohazard precautions.
May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
May be exposed to chemicals that may be hazardous.
May be called on to work or attend meetings other than routinely scheduled hours.
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.
Laboratory experience preferred but not required
Interpersonal skills to establish and maintain professional relationships.
Decision-making skills. Uses authority appropriately in making sound judgments in a timely manner.
Professional communication both written and oral, which is clear and precise.
Must keep management informed on any operational or personnel issues that arise.
Organizational skills – time management, priorities, deadlines, goals.
Flexibility – ability to effectively manage change and positively influence others.
Integrity and discretion – ability to maintain confidentiality.
Ability to perform under pressure and work under stressful situations.