Overview

Job Summary

As a QA Laboratory Supervisor, you will assist in overseeing a broad range of laboratory work requiring application of professional judgment, serve as a subject matter expert for laboratory processes and product lines. You will be responsible for instrument validations, instrument maintenance, coordinate projects between multiple Werfen sites and departments and oversee the laboratory team's training, and ensure a balance workload. You will also assist in the daily oversight of laboratory activities, reliability testing, functional testing, general housekeeping, and escalate concerns or changes as needed.

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

Responsibilities

Key Accountabilities

• Oversee the execution of: Reliability Testing, GEM Functional Testing, GEM Prescreen Testing, Value Assignment for Werfen products, Proficiency Testing, Validation Activities, and etc.
• Actively participates in writing and updating laboratory procedures.
• Trains and develops team members, as appropriate, to achieve duties and responsibilities.
• Coordinates laboratory activities between multiple departments and sites, while providing resolution of product malfunction concerns in a timely manner.
• Maintains inventory of laboratory supplies, reagents, and other consumables. Ensure proper storage conditions and expiration dates and that material is disposed of in a timely manner and appropriately.
• Oversees the Proficiency Testing Program.
• Escalates abberant results from product testing to appropriate management as necessary.
• Participates in cross-functional meetings to present data, may involve slide creation, presentations, and maintain detailed and accurate records.
• Responsible for coordinating the maintenance of laboratory equipment utilized.
• 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.
• Ten years or S years (with a Master's) of clinical laboratory experience.
• Atleast 3 years of supervisory experience in managing a laboratory environment and related personnel. Hospital experience preferred.
• Lean and Six Sigma certification is a plus.
• Experience with Power BI and Minitab is a plus.

Skills & Capabilities:

• Expert knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practices (GWP), and Product Quality Escalation.
• Knowledge of equipment maintenance processes and techniques.
• Excellent oral and written communications, problem solving, and statistical knowledge.
• Ability to present complex laboratory information to a wide range of audience.
• Excellent in MS office applications particularly Excel, Work and PP.
• 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:
<5%