QC Analyst II

WerfenOrangeburg, NY
10d$24 - $29

About The Position

Overview Position Summary: Performs analyses of Clinical Chemistry, Co-Oximeter, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality and GMP requirements.

Requirements

  • B.S./B.A. Degree in Science or Medical Technology or equivalent required, plus 2 years clinical laboratory experience with a basic knowledge of quality control principles.
  • This position requires the ability to lift and move materials per current OSHA standards.

Responsibilities

  • Performs automated and manual assays as detailed in departmental/plant SOPs and QC Monographs including raw material, in-process and finished product.
  • Interprets test results against specifications and decides if assays pass or fail.
  • Maintains documentation of all work performed in accordance with GMP requirements.
  • Evaluates product complaints upon Team Leader or Team Champion's request.
  • Performs product stability, proficiency, environmental testing and water system testing.
  • Responsible for routine preventive maintenance, general trouble shooting, general cleanliness and calibration of Lab equipment.
  • Updates departmental SOP's and QC Monographs as directed by Team Leader or Senior QC Analyst.
  • Performs microbial testing per SOP's and QC Monographs.
  • Orders required laboratory supplies, reagents and other consumables.
  • Monitors proper storage conditions and expiration dates.
  • Disposes hazardous and biohazardous materials.
  • Other duties as directed by Team Leader or Sr. QC Analyst.
  • Maintains samples in accordance with established procedures.
  • Maintains statistical process control charts and other tracking reports
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