Job Description

Lighthouse Lab Services has an exciting opportunity to be directly involved in bringing up a clinical laboratory located in Franklin, TN! From obtaining CLIA certification, to establishing and verifying performance specifications of a laboratory developed (high-complexity) test, and to commercial product launch to begin testing of patient samples! This laboratory is based in the UK and focuses on early detection of cancer cells using analytical chemistry with Perkin Elmer instrumentation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Writes new SOPs as needed and reviews SOPs biannually (at minimum) to ensure they are current.

• Oversees equipment management to ensure all equipment are up to date on their maintenance schedule (e.g., daily/weekly/monthly/etc. maintenance tasks and yearly calibration/preventative maintenance).

• Responsible for the completion and close out of Nonconformances and CAPAs.

• Responsible for organizing proficiency testing (or Alternative Performance Assessment) and instrument/method comparison testing (including planning, scheduling, and reviewing of results).

• Monitors on-going test performance including review of quality control data (including but not limited to reagent qualifications, equipment qualifications, and control charting).

• Gathers and tracks pre-analytic, analytic, and post-analytic key indicators of quality.

• Serves as the Chemical Hygiene Officer.

MINIMUM QUALIFICATIONS:

• Current Tennessee Medical Laboratory Supervisor License

• Bachelor’s, Master’s or Doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology from an accredited institution

• At least 4 years of supervisory experience in a high-complexity laboratory

• Background in analytical chemistry and mass spectrometry

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong knowledge of regulatory standards such as CLIA, Tennessee Medical Laboratory Board, and the College of American Pathologists (CAP)

• Direct experience in obtaining laboratory certification (initial and/or recertification) from CLIA, Tennessee Medical Laboratory Board, and CAP

• Proficient in instrumentation maintenance (e.g., spectrophotometers) and troubleshooting

• Experience with Laboratory Information Systems (LIS) is preferred

• Exemplary in Good Documentation Practice (GDP) and Good Laboratory Practice (GLP)

• Strong background in laboratory safety (including, but not limited to, fire, electrical, bloodborne pathogens, chemical, and waste disposal)

• Strong leadership and organizational skills

• Ability to train and mentor staff effectively

• Excellent communication skills, both written and verbal

• Strong analytical and problem-solving abilities
  

WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:

• Clinical laboratory setting with exposure to biohazardous/biological specimens (e.g., blood and serum), chemicals, and instruments

• Use of personal protective equipment (PPE) (e.g., gloves, lab coat, googles) as required

• Must provide documentation of Hepatitis B vaccination or immunity

• Must be willing to take a color-blindness test

• Must be willing to work holidays as required

Benefits and Salary :

• 90-100k

• Medical, Dental and Vision Plans

• 401(k) Plan with company match

• Paid Time Off (PTO)

• Paid Sick Leave

• Paid Holidays

About Us:

Lighthouse Lab Services specializes in clinical laboratory recruitment and consulting. With over 20 years of experience, we help place professionals in positions ranging from entry-level Histotechnicians to Laboratory Managers. We recruit nationwide for permanent and travel positions with hospitals, reference labs, and specialty clinics.

Lighthouse Lab Services is committed to equal employment opportunity (EEO) and providing reasonable accommodations for individuals with disabilities.

844-914-0785 | lighthouselabservices.com

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