QC Analyst II
About The Position
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. 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.
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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
