QA Laboratory Technologist III

Werfen

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.

Job Summary

As a QA Laboratory Technologist III, you will evaluate materials and products to ensure they meet our high quality standards. You will work within a team to perform a broad range of laboratory work requiring application of professional judgment, perform specialized studies and/or specific assignments within the Product Quality Laboratory. Responsibilities include validations, reliability testing, functional testing, proficiency survey testing and general housekeeping.

General laboratory tasks include: inventory management, data analysis, calibration and maintenance, quality control and laboratory testing.

Key Accountabilities

• Responsible for the execution of: Reliability Testing, GEM Functional Testing, GEM Prescreen Testing, Value Assignment for Werfen products, Proficiency Testing, Validation Activities, and etc.
• Ability to interpret clinical proficiency survey results of difficult complexity.
• Performs calibration coordination: maintain accurate calibration records in SAP, lead potential out-of-tolerance equipment investigations, train staff, and execution of calibration and maintenance for laboratory equipment.
• Maintains inventory of laboratory supplies, reagents, and other consumables. Monitors proper storage conditions and expiration dates are maintained.
• Train other QA Laboratorians and Medical Technologists on protocols, techniques, and project specific studies.
• Participate in cross-functional meetings to present data, may involve slide creation, presentations, and maintain detailed and accurate records.
• Responsible for Proficiency Survey scheduling including meetings and shipments.
• Manage data for survey results, calibrations, Reliability and Functional testings and other studies.
• Other duties as directed by the Manager/designee.

Networking/ Key relationships Work with various functional groups throughout the organization including other Werfen sites.

Minimum Knowledge & Experience required for the position:

• Bachelor's Degree in science related field or Medical Technology. Medical Technologist Preferred.
• Five years or 2 years (with a Master's) of clinical laboratory experience.
• Lean and Six Sigma certification is a plus.

Skills & Capabilities:

• Expert knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practices (GWP), and Product Quality Escalation.
• Knowledge of equipment calibration, maintenance processes, and techniques.
• Excellent oral and written communications, problem solving, statistical knowledge.
• Proficient in MS office applications particularly Excel, Work and PP. Minitab and Power BI is a plus.
• Ability to work safely and efficiently in a busy biohazardous laboratory environment.
• Reliable and dependable.
• Ability to lift and move materials per current OSHA standards.

Travel requirements: N/A

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

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com