QA Laboratory Technologist III

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:

• Bachelors Degree in science related field or Medical Technology. Medical Technologist Preferred.
• Five years or 2 years (with a Masters) 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