What are the responsibilities and job description for the QC Analyst II position at Werfen North America?
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.
Responsibilities
Key Accountabilities
Essential Functions
Min Knowledge & Experience Required for the Position:
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.
Responsibilities
Key Accountabilities
Essential Functions
- 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
Min Knowledge & Experience Required for the Position:
- 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
Salary : $24 - $29