GLP Quality Assurance Specialist

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.

We test of a variety of instrumentation including UPLC, HPLC, GC, and LCMS technologies. We offer an innovative and collaborative team environment, and the opportunity to develop expertise on a wide variety of analytical instruments! If you are looking for an opportunity to work for an exciting growth oriented company, we look forward to talking with you!

Job Description

Develops, implements, and administers quality programs in accordance with applicable requirements, Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs), and in compliance of ISO/IEC 17025:2005 to ensure integrity and consistency of quality systems and training. Verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations (GLPs) by performing study protocol, data, report, in-lab phase inspections where applicable. Leads internal facility, supplemental, and process inspections, process improvement and harmonization efforts that promote best practices, and delivers training (or mentoring) in quality/regulatory matters. In addition to reviewing SOPs, initiates and updates SOPs. Sufficiently confident in regulatory knowledge to act as a point person for Operational liaison. Hosts client inspections, and regulatory inspections.

Essential Duties and Responsibilities:

  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Conducts internal and external audits including performing facility, vendor, test site, protocol, data, report, and in-lab phase inspections to verify conformance to applicable SOP and regulatory requirements
  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
  • Performs study sign-off including but not limited to QA statement preparation/review (internal/external) and report finalization
  • Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records, archive records)
  • Hosts client and regulatory visits
  • Develops and implements SOPs
  • Peer reviews SOPs and other controlled documents
  • Conducts SOP release meetings if applicable
  • Develops and implements training programs, including delivery of quality/regulatory training
  • Defines, maintains, and implements new employee training
  • Develops and coordinates initiatives to advance quality
  • Participates in process improvement and harmonization efforts that promote best practices.
  • Reviews method validation reports
  • Monitors control charts
  • Notifies management of service failures
  • 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
  • 2-3 years in laboratory operations and/or laboratory quality control/assurance
  • Successful performance of self-directed projects
  • At least 3 years of experience as a quality auditor in a GxP-regulated environment
Education/Experience (BMQ):
  • Bachelor's degree - experience may be substituted for education
  • Excellent written and verbal communication skills
  • Strong aptitude and proficiency in spreadsheets and word processing software
  • Knowledge of applicable GLP/GMP regulations and requirements

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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