Clinical Lab Specialist

Position Summary

The Clinical Laboratory Scientist (CLS) / Radiopharmacy Technician supports the manufacturing, compounding, and quality control of clinical and radiopharmaceutical products in compliance with State and Federal regulations. This role works closely with cross-functional teams to ensure safe, accurate, and timely production while maintaining strict quality and compliance standards. This is a role well suited to an ambitious professional, looking for the next step in their career.

Key Responsibilities

• Perform testing in areas such as:
• Allergy testing
• Clinical chemistry (e.g., metabolic panels, enzyme assays)
• Hematology (CBCs with no manual differentials).
• Perform complex compounding and manufacturing activities, including cyclotron operation and chemistry module operation, under supervision as required by State and Federal law
• Execute quality control testing using analytical equipment such as TLC, HPLC, and GC
• Participate in complex inspections, maintenance, and troubleshooting to support manufacturing and testing equipment
• Implement approved SOP updates related to production and quality control processes
• Conduct Daily, Weekly, Monthly, and Quarterly Preventive Maintenance (PM) checks on: Cyclotrons, Chemistry Modules, Quality Control (QC) equipment, in accordance with established SOPs
• Support logistics and distribution activities, including: Preparing products for shipment, Coordinating courier schedules, Completing required documentation and records
• Conduct laboratory tests on blood, tissue, and other specimens
• Operate and maintain clinical lab equipment
• Report and validate test results used by physicians for diagnosis and treatment
• Adhere to all cGMP, cGLP, CLIA, CAP, and regulatory requirements (State, Federal, and accrediting bodies)
• Maintain accurate and complete batch records, QC documentation, and logs
• LIS build and LIS maintenance
• Support internal audits, inspections, and corrective actions as needed

Qualifications & Requirements

• Education: Bachelor’s degree in Clinical Laboratory Science, Chemistry, Biology, or related field (required)
  • Coursework must include:
  • 16 semester hours of chemistry, including analytical and biological chemistry.
  • 16 semester hours of biological sciences, including microbiology, hematology, and immunology.
  • 3 semester hours of physics, math, or statistics.
• Experience
  • Experience working in a sterile or clean room laboratory/environment.
  • Experience in clinical laboratory, radiopharmacy, or regulated manufacturing environments preferred
  • Hands-on experience with analytical instrumentation (TLC, HPLC, GC) preferred
• Licensure & Certifications
  • CLS license or applicable laboratory certification (required based on state regulations)
• Skills & Abilities
  • Analytical Chemistry Equipment and Processes (HPLC, GC, TLC)
  • Strong attention to detail and ability to follow SOP-driven processes
  • Detail oriented and have strong critical thinking skills.
  • Work well independently.
  • Basic computer skills such as spreadsheet, word processing and e-mail.
  • Strong verbal and written communication skills.
  • You can lift up to 100Lbs
  • Willing to work night shifts and alternating shifts as needed.

Compensation

The hourly range for this position is $45.00-60.00/hour. The actual compensation for this role will be determined by a variety of factors, including but not limited to the candidate’s skills, education, and experience.