Schedule: Variable hours between 6 am and 5 pm, weekend and holiday availability required, rotating on-call responsibilities.
Reports to: Laboratory Testing Manager
Job Summary:
This position is responsible for performing and maintaining high complexity high throughput laboratory testing on blood donor specimens, interpreting and reporting results, performing quality control and quality assurance procedures, participating in regulatory inspections and complying with all applicable local, state, federal laboratory requirements, and following current Good Manufacturing Practices (cGMP).
Essential Job Duties:
Demonstrates proficiency and follows laboratory standard operating procedures and policies by adherence to quality assurance guidelines for equipment and work area, documenting corrective action to any non-conforming event.
Performs all assigned duties in compliance with internal SOPs and external regulations.
Provides technical support/liaison to center operations and assures quality customer service to all customers.
Performs high complexity high throughput FDA required blood donor testing (e.g., ABORh, antibody screen, and infectious disease testing).
Performs scheduled instrument maintenance and maintains all QC logs; analyzes complex problems; and recommends additional service, as needed.
Performs other QA tasks, e.g., proficiency testing, competency assessment, maintains records of QA activities.
Prepares reagents, maintains an adequate supply of materials for test procedures and manages inventory to effectively reduce departmental waste/expense.
Exercises clinical judgment in assessing priorities while identifying problems and offering solutions to test systems independently or through the appropriate department channels, i.e., contacts tech support to troubleshoot with a specialist, when necessary, to resolve the issue or set-up service when appropriate.
Assists with writing, review and revision of internal standard operating procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, CLIA, AABB, FDA, OSHA.
Participates in planning and implementing change through participation in staff meetings, task forces or projects.
Maintains donor testing laboratory in a clean, organized state to minimize and contain amplicon contamination.
Assists with training and competency assessment.
Demonstrates a commitment to working in a strong team environment and strict adherence to CCBC employee handbook and all company policies.
Attendance and punctuality are essential functions of this position.
Note: The duties and responsibilities described above are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands.
Requirements
Required Qualifications and Skills:
MT (ASCP) or MLS (ASCP) is required and must be maintained
Current California CLS license is required and must be maintained
Knowledge of safety precautions required for working with blood borne pathogens
Preferred Qualifications and Skills:
1-2 years of laboratory testing experience
Donor Testing and/or IRL experience is preferred
Work Environment:
Environmentally controlled laboratory environment
Fast paced environment with occasional high pressure or emergent situations
Possible exposure to bloodborne pathogens
Must wear Personal Protective Equipment (PPE) such as gloves, mask or goggles
Could be required to enter walk-in freezer at 32°F or lower
Physical Demands:
Frequent standing, walking, grasping, carrying and speaking
Occasional sitting, reaching, bending and stooping
Lifting, carrying, pushing and pulling up to 50 pounds, with assistance, if needed
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