Quality Assurance Specialist I

Madison, Wisconsin

This job has expired.

Company Description

Interested in contributingto improving and saving lives? Eurofins Food Chemistry Madison is growing and we're looking for amazing team members to join us.

In 2021 we moved into a brand new ISO 17025 accredited laboratoryin Madison, WI designed to conductfood chemistry testingspecializing in infant formula, sole-source nutrition products, hemp and CBD, dietary supplements, and a variety of botanicals. Ourtesting portfolio includes vitamins, minerals, contaminants, pesticides and shelf-life studies.

Job Description

The Quality Assurance Specialist is responsible for supporting the local implementation and operation of the Quality Management System. The role aims to ensure the site remains in a state of GMP/GLP/ISO compliance providing expert advice relating to GMP/GLP/ISO and by actively participating in investigations, audits, data reviews, validation projects, and the delivery of related training, etc.

Essential Duties and Responsibilities:

  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Applies GMP/GLP/ISO in all areas of responsibility, as appropriate
  • Supports the implementation of the quality management system, helping to ensure that site specific requirements are addressed locally
  • Monitors and reports on appropriate site metrics and data trends related to the performance of the site quality management system for input into the Management Review Process
  • Reviews and approves site quality documents (SOP's, Policies, etc.) to ensure compliance with GMP/GLP/ISO, Eurofins document management procedures and other applicable quality standards
  • Supports the supplier qualification program by participating in assessments and leading third party audits
  • Provides regulatory approval of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to release to the Client
  • Supports the QA internal audit program by scheduling, planning leading, reporting, and following up of system, process and facility audits
  • Participates in projects to ensure facilities, utilities, equipment and computer systems are appropriately validated/ qualified; approval of key validation deliverables
  • Reviews and approves investigations deviations, OOS, customer complaints, etc. into the cause and resolution of quality defects
  • Participates to the development and delivery of training
  • Provide advice and guidance and independent review to the site on aspects of quality and compliance
  • Manages the global supplier qualification program
  • Provides review and quality approval of study-related documentation (e.g., protocols, reports, certificates of analysis, methods) prior to release to the client.
  • Conducts all activities in a safe and efficient manner
  • Performs other duties as assigned


Basic Minimum Qualifications (BMQ):

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
  • A minimum of 1 year QA/GMP experience
  • Knowledge of Good Manufacturing Practice Regulations
  • Experience of industry quality systems/standards, e.g. ICHQ10, ISO 17025
  • Excellent interpersonal/ organizational skills, e.g. communication, decision making, negotiating, problem solving
  • Experience in process improvement
  • Customer serviced orientated, i.e. ability to interact effectively with clients and regulatory authorities
  • Ability to work unsupervised
  • Computer literate
Education/Experience (BMQ):
  • A minimum of a Bachelor's Degree in a scientific field

Additional Information

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work!

Life at Eurofins is a meritocracy, where people are empowered to make decisions and are rewarded for their success, allowing them to advance quickly. Become your most extraordinary self with support and development throughout your career.

We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, vacation, personal days, and dental and vision options.

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

This job has expired.

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