QC Analyst II

Position Summary:

• 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

• N/A

• To be determined based on department needs

• Functional/technical skills

• 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.

• No

• No