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