HPC Laboratory Specialist (Levels 1-3)

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**Lab Scientist Positions are available at levels 1-3 depending on experience and education.**

The HPC Laboratory Specialist I is an entry level position that, under general direction, performs complex, professional, technical, and analytical work. This position completes Cellular Therapy Lab (CTL) processing and routine standardized clinical tests.

Essential Responsibilities:

Responsibilities listed in this section are core to the position. Inability to perform these responsibilities with or without an accommodation may result in disqualification from the position.

• Performs processes using aseptic techniques including red cell depletions, plasma removal, and cryopreservation of components and complies with all hospital and laboratory safety policies and procedures including the appropriate use of PPE.

• Assists in Bone Marrow Harvest procedures.

• Receives, inspects, and documents receipt of HPC products and clinical specimens. Verifies labeling is complete and accurate.

• Performs and documents daily QC and routine cleaning and/or maintenance of equipment per laboratory SOP.

• Responsible for performing equipment maintenance, quality control and/or calibration of HPC equipment, and properly documenting actions taken based on approved schedule.

• Performs calculations and maintains accurate records of component processing per laboratory SOP.

• Provides on-call coverage during off-hours when needed.

• Participates in performance improvement activities and supports the laboratory in meeting all regulatory and accreditation standards.

• Recognizes problems, and initiates troubleshooting steps to evaluate failures. Notifies management and contacts manufacturer for additional assistance or field service support, if required per laboratory SOP.

• Assist with validating new equipment, new methodologies, and procedural protocols.

• Follows established company and department policies and procedures. Follows the guidelines for safety, environmental, and infection control and follows cGTP regulations.

• Performs high complexity product testing requiring advanced knowledge in a prompt and reliable manner according to established hospital and departmental policies.

• Takes appropriate action in response to critical values or unusual or unexpected results, and documents action taken.

• Completes accurate data collection and documentation for all activities performed.

• Participates in laboratory quality activities including quality monitoring and auditing, occurrence/deviation documentation, and performance improvement.

• Completes competency assessment per HPC laboratory SOP.

General Responsibilities:

• Performs other duties as assigned

Minimum Qualifications (Level 1):

Education: Associates Degree in Medical Laboratory Technology or graduate of a MT/MLS/CLS program required.

Experience: 0 to 3 years of experience as a HPC Lab Specialist required. 2 years of previous clinical lab experience required.

Licensure/Certifications/Registrations Required: National Certification by a recognized organization (ASCP, AABB, AMT, or equivalent) as a MT, CLS, MLS, BB, H, or CABP required.

Minimum Qualifications (Level 2):

Education: Associates Degree in Medical Laboratory Technology or graduate of a MT/MLS/CLS program required.

Experience: 3 or more years of experience in processing, cryopreservation, and handling of commercial/clinical trial cellular therapies in HPC lab required.

Licensure/Certifications/Registrations Required: National Certification by a recognized organization (ASCP, AABB, AMT, or equivalent) as a MT, CLS, MLS, BB, H, or CABP required.

Minimum Qualifications( Level 3):

Education: Associates Degree in Medical Laboratory Technology or graduate of a MT/MLS/CLS program required.

Experience: 5 or more years of experience in processing, cryopreservation, and handling of commercial/clinical trial cellular therapies in HPC lab required.

Licensure/Certifications/Registrations Required: National Certification by a recognized organization (ASCP, AABB, AMT, or equivalent) as a MT, CLS, MLS, BB, H, or CABP required.

Knowledge, Skills and Abilities:

• Demonstrates analytical ability and judgement.
• Must have the skills to perform required laboratory testing.
• Must be able to work as part of a team and follow instructions.
• Must be able to consistently and dependably report to work as scheduled.
• Must be able to maintain legible, accurate, and organized records.
• Ability to exercise discretion in handling confidential information and exercise sound judgment.
• Ability to work under stress of time constraints and heavy workload demands requiring accuracy.
• Must possess ability to understand various operations, policies, and procedures.
• Ability to work and communicate with co-workers and other caregivers and meet their needs in a professional, polite, courteous, compassionate, and cooperative manner.
• Must demonstrate a high level of initiative, effort, and commitment towards establishing priorities and completing assignments.
• Knowledge and understanding of HPC processing theory and processes.
• Knowledge of laboratory principles and techniques.
• Knowledge of laboratory safety procedures.
• Familiar with regulatory requirements including FACT, FDA, and Joint Commission.
• Good communication skills, computer knowledge, and the ability to work with others as a team to ensure quality patient care.
• Demonstrates a high level of integrity and honesty in maintaining confidentiality.
• Maintains professional growth and development through continuing education activities.

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