What are the responsibilities and job description for the QA Laboratory Technologist III position at Werfen North America?
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.
Responsibilities
Key Accountabilities
Work with various functional groups throughout the organization including other Werfen sites.
Qualifications
Minimum Knowledge & Experience required for the position:
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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.
Responsibilities
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.
Work with various functional groups throughout the organization including other Werfen sites.
Qualifications
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.
- 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.
N/A