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Instrumentation Laboratory - Bedford QC Analyst III in Orangeburg, New York


Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position 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 requirements. Directs and coordinates activities of QC Analyst I and QC Analyst II

Key Accountabilities: o Performs automated and manual assays as detailed in departmental/plant SOP's and QC Monographs including raw material, in-process and finished product. Interprets test results against specifications and decides if assays pass or fail e Maintains documentation of all work performed in accordance with GMP requirements. Evaluates product complaints upon Team Leader's request. (QA- Bedford). Performs product stability, proficiency and environmental testing (Orangeburg). Responsible for routine preventive maintenance, general troubleshooting, general cleanliness and calibration of Lab equipment. Maintains statistical process control charts and other tracking reports. Provides training and limited supervision for QC Analysts 11 and I. Assists Team Leader in final data review prior to product release. Updates departmental SOP's and QC Monographs/Procedure and performs appropriate Method validations as necessary. Orders required laboratory supplies, reagents and other consumables, monitors their proper storage and expiration dates; disposal of biohazardous and hazardous materials. Performs special assignments or other duties as directed by Team Leader or Sr. QC Analyst 0 Assists Team Leader in complaint analysis and stability testing. (QA - Orangeburg. Performs microbial testing per SOP's and QC Monographs. (Orangeburg. Maintains retain samples in accordance with established procedures. (QA - Orangeburg) Budget managed (if applicable) N/A Internal Networking/Key relationships To be determined based on department needs Skills & Capabilities: Functional/technical skills

Min Knowledge & Experience required for the position: A B.S./B.A. Degree in Science or Medical Technology or equivalent required, plus 4 years clinical laboratory experience with a thorough knowledge of Quality Control principles and GMP regulations. Physical Requirements This position requires the ability to lift and move materials per current OSHA standards. International Mobility: Required: no Travel requirements: No

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

Job ID: 2021-4366

Shift: 2nd

External Company URL:

Street: 526 Route 303