Overview

Werfen

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

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

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Functional/technical skills

Qualifications

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.

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.

www.werfen.com