Jobs · Management · North Carolina

Lead CLS (T-F, 12-10:30 PM)

Octapharma Plasma, Inc. · Charlotte, NC · 2 wk ago
ManagementFull-time

Job Summary

Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We’re growing fast. There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Lead CLS (T-F, 12-10:30 PM)

About the role

This Is What You’ll Do
Performs a full range of laboratory tests, from the most routine to the most complex, with no supervision.
Responsible for specimen processing, test performance and reporting test results.
Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of test results.
Ability to manage individual daily workflow independently.
Identify problems that may adversely affect test performance or reporting of test results and resolve the problem or bring it to the immediate attention of supervisor, manager, or director.
Proficient on at least two (2) or more testing platforms.
Ability to perform advanced troubleshooting on two (2) or more testing platforms.
Perform FDA, CLIA, and other required tests on blood and blood products according to Octapharma Plasma approved SOPs or special protocols.
May be cross-trained to perform the following: Viral marker testing, Syphilis screen, Sickle cell screen, Total protein, Protein electrophoresis, ABO, Rh, antibody detection, antibody identification and red cell phenotyping, Anti-D Titers, Nucleic Acid Testing (NAT)
Operate and interact with an array of complex precision instruments and a variety of highly automated and electronic equipment.
Perform glycerolyzation and deglycerolyzation procedures to prepare immunogen cell units for storage or distribution.
Maintain complete and accurate records of all events, tasks and testing related to product testing and eventual release or distribution.
Perform and document laboratory testing and instrument quality control, proficiency testing, preventive maintenance, troubleshooting, calibration and validation as required.
Maintain records that demonstrate proficiency testing samples are tested in the same manner as donor samples.
Perform and document laboratory testing associated with Comparability Studies between Analyzers and/or Methods.
Supports instrument maintenance and service by: Removing instrument from service, Returning instrument from service, Arrange for Technical Service, as needed, Handles and coordinates complex issues, Qualify to act as a General Supervisor as defined by CLIA, Evaluate and identify potential improvements for testing, production, and validation protocols.
Write and revise standard operating procedures and forms as needed.
Act as technical advisor for other testing personnel.
Participate in Laboratory Deviation Management as a Deviation Initiator and Investigator.
Qualify to act as a Designated Trainer: process, evaluate and document initial training and competency assessment of other testing personnel.
Provide on call coverage per rotational schedule along with other cross trained individuals as needed.
Follow Octapharma Plasma approved SOPs whenever test systems are not within the laboratory’s established acceptable levels of performance.

Responsibilities

  • Performs a full range of laboratory tests, from the most routine to the most complex, with no supervision.
  • Responsible for specimen processing, test performance and reporting test results.
  • Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of test results.
  • Ability to manage individual daily workflow independently.
  • Identify problems that may adversely affect test performance or reporting of test results and resolve the problem or bring it to the immediate attention of supervisor, manager, or director.
  • Proficient on at least two (2) or more testing platforms.
  • Ability to perform advanced troubleshooting on two (2) or more testing platforms.
  • Perform FDA, CLIA, and other required tests on blood and blood products according to Octapharma Plasma approved SOPs or special protocols.
  • May be cross-trained to perform the following: Viral marker testing, Syphilis screen, Sickle cell screen, Total protein, Protein electrophoresis, ABO, Rh, antibody detection, antibody identification and red cell phenotyping, Anti-D Titers, Nucleic Acid Testing (NAT).
  • Operate and interact with an array of complex precision instruments and a variety of highly automated and electronic equipment.
  • Perform glycerolyzation and deglycerolyzation procedures to prepare immunogen cell units for storage or distribution.
  • Maintain complete and accurate records of all events, tasks and testing related to product testing and eventual release or distribution.
  • Perform and document laboratory testing and instrument quality control, proficiency testing, preventive maintenance, troubleshooting, calibration and validation as required.
  • Maintain records that demonstrate proficiency testing samples are tested in the same manner as donor samples.
  • Perform and document laboratory testing associated with Comparability Studies between Analyzers and/or Methods.
  • Supports instrument maintenance and service by: Removing instrument from service, Returning instrument from service, Arrange for Technical Service, as needed, Handles and coordinates complex issues, Qualify to act as a General Supervisor as defined by CLIA, Evaluate and identify potential improvements for testing, production, and validation protocols.
  • Write and revise standard operating procedures and forms as needed.
  • Act as technical advisor for other testing personnel.
  • Participate in Laboratory Deviation Management as a Deviation Initiator and Investigator.
  • Qualify to act as a Designated Trainer: process, evaluate and document initial training and competency assessment of other testing personnel.
  • Provide on call coverage per rotational schedule along with other cross trained individuals as needed.
  • Follow Octapharma Plasma approved SOPs whenever test systems are not within the laboratory’s established acceptable levels of performance.

Requirements

  • Bachelor of Arts/Bachelor of Science degree in a laboratory science or Medical/Clinical Laboratory Science from an accredited institution.
  • Two (2) years’ experience performing clinical laboratory tests, required.
  • Minimum of one (1) year performing Charlotte Testing clinical laboratory scientist essential job functions required.
  • Must qualify as a general supervisor in accordance with CLIA Regulations 493.1423 Standard; Testing Personnel Qualifications.
  • ASCP certification or eligibility preferred.
  • New York and California State testing requirements preferred.
  • Able to work diverse shifts and overtime hours, as required.
  • Able to work in a variety of different test areas as required after appropriate training.
  • Self-motivated with the ability to work with minimal supervision while able to take direction.
  • Able to be flexible to changing priorities.
  • Excellent verbal, written and interpersonal skills, including the ability to assist less experienced staff.
  • Proficient with computer software in an office and laboratory environment.
  • Has the knowledge of or ability to learn applicable software used in the course of the job: sample management, sample, and QC test result management, drafting laboratory or QA procedures and other tasks as required.
  • Ability to read, understand, write, and follow SOPs, validation protocols, etc. and to complete documentation in a clear, accurate manner.
  • Excellent organizational skills, provides direction to others, and strong attention to detail.
  • Organizes time and priorities to achieve business results in a timely manner.

Qualifications

  • Ability to uphold and demonstrate OPI’s Values.

Skills

  • Ability to uphold and demonstrate OPI’s Values.

Benefits

Inner satisfaction. Outstanding impact.

Pay

TBD

Schedule

TBD

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