QA Laboratory Technologist III at Werfen GmbH

Bedford, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

0.0

Posted On

20 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Good Laboratory Practice, Good Manufacturing Practices, Product Quality Escalation, Equipment Calibration, Maintenance Processes, Oral Communication, Written Communication, Problem Solving, Statistical Knowledge, MS Office, Excel, Minitab, Power BI, Training, Data Analysis, Inventory Management

Industry

Medical Equipment Manufacturing

Description

Overview 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 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. 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. 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

Responsibilities

The QA Laboratory Technologist III is responsible for executing various testing and validation activities to ensure product quality. This includes managing laboratory supplies, training staff, and participating in cross-functional meetings.