General Supervisor - 2nd Shift (ADX-116-20)

POSITION SUMMARY:

At the designation of the Laboratory Director, oversees day to day operations at the laboratory, manages testing personnel, monitors inventory, ensures compliance with quality management programs and procedures, reviews quality reports. Oversees the validation of new tests and the successful training of testing personnel on all relevant procedures and policies. The General Supervisor also serves as the Safety Officer.

RESPONSIBILITIES:

The General Supervisor is responsible for the day-to-day operations of the laboratory.

• Training and routine competency assessment of testing personnel.
• Management of laboratory testing personnel.
• Monitoring reagent and consumable consumption and purchasing.
• Enforcing Quality standards and ensuring adherence of staff to the Quality management and improvement program.
  
  • With the Laboratory Director, establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.
• Ensuring instrumentation is functioning properly and maintenance is being performed.
• Ensure new lots or new shipments of existing lots have successful performance evaluations prior to routine use.
• Performing responsibilities that were delegated from the Molecular Laboratory Director:
  
  • Assuring remedial action is taken whenever test system results deviate from established specifications;
  • Ensuring test results are not reported until all corrective action has been taken and the test system is functioning properly;
  • Providing orientation and training to testing personnel and evaluating competency of the staff at 6 months and 12 months post hire date, then at least annually thereafter.
• Improve operational efficiency of clinical assays and processes in collaboration with R&D staff under the Lab Director's guidance.
• Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
• Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
• Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
• Ensures that proficiency testing samples are tested as required in SOP-008: Proficiency Testing (PT).
• Manages and oversees state, federal and/or other accreditation agency compliance program for clinical testing licensure, and associated proficiency testing program.
• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data.
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.

QUALIFICATIONS:

The General Supervisor must be must meet the following requirements:

• Qualified Laboratory Director of high complexity testing, or;
• Qualified Technical Supervisor of high complexity testing, or;
• MD, DO, DPM, doctorate, master's or bachelor's degree in lab science and
  
  • 1 year lab training/experience in high complexity testing, or;

• Doctorate in the physical sciences and
  
  • 1 year lab training/experience in high complexity testing.
• Associate degree in lab science or medical laboratory technology and
  
  • 2 years lab training/experience in high complexity testing, or;

• Previously qualified or could have qualified as general supervisor under federal regulations on or before Feb. 28,1992 (42 CFR 493.1462).
• Passed the HHS exam for technologist between March 1, 1986 and Dec 31, 1987 and prior to Jan 1,1994, met the requirements of a general supervisor in effect before Feb. 28,1992.
• Prior to Sept 1,1992, served as general supervisor of high complexity testing and
  
  • prior to April 24,1995 graduated from an accredited medical laboratory training program or
  • high school graduate or equivalent and have completed a 50 week military program of Medical Laboratory Specialist or
  • 2 years clinical lab training/experience in high complexity testing.

• Prior to Sept 1,1992 served as a general lab supervisor of high complexity testing, and
  
  • High school graduate or equivalent, and
  • 10 years of lab training/experience in high complexity testing, including 6 years supervisory experience between Sept 1,1982 and Sept 1, 1992.