QC Analyst II
2 weeks ago
OverviewPosition Summary:Performs analyses of Clinical Chemistry, Critical Care, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality standards and GMP requirementsResponsibilitiesKey AccountabilitiesEssential 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
Budget Managed (if applicable): N/A
Internal Networking/Key Relationships:To be determined based on department needs
Skills & Capabilities: Functional/technical skills
QualificationsMin 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.
Physical Requirements:This position requires the ability to lift and move materials per current OSHA standards.
International Mobility: Required: No
Travel requirements: No
The hourly wage range Werfen reasonably expects to pay for the position is $24 to $29. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.
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