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QA Laboratory Supervisor

Werfen
United States, Massachusetts, Bedford
180 Hartwell Road (Show on map)
Jan 16, 2025
Job Information
Number
ICIMS-2024-8164
Job function
QA&RA
Job type
Full-time
Location
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States
Country
United States
Shift
1st

About the Position
Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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%

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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