Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Primary responsibility over all River Falls Genomics business unit and serves as back-up to the other Quality representatives for the other business units under the same Eurofins Legal Entity (ELE). This position combines the responsibilities of a:

• Management Representative (as required to maintain ISO 17025, CLIA, CAP, GLP accreditations and certifications)
• Safety Officer (per OSHA, EPA, DEQ and other safety regulations applicable to the River Falls location)
• Quality Assurance Manager (as dictated by customer requirements)

Responsible for establishing and maintaining the Quality Management System for this business unit and promoting a quality culture throughout the organization. Represents the company in internal and external audits (including surveillance audits by notified body, and customer audits). Performs routine activities to ensure compliance with EBDI Quality Management System.

Communicates QA/QC processes and records for different tests performed in the business unit, captured by LIMS, and other lab capabilities to appropriate persons including staff, external staff, vendors, clients, and inspectors.

Collaborates with managers and supervisors and fosters a team environment. Drives continuous improvement through root cause analysis and trending.

This position may require 5% travel as audit schedule dictates.

Responsibilities and Duties:

• Provides training and advise to management, supervisors and staff on quality and safety aspects and regulations and internal policies
• Follows and promote EBDI’s Quality System and standards that apply to EBDI
• Encourages and adheres to safe practices
• ISO 17025 accreditation – in collaboration with the other business unit Quality representatives, maintain ISO 17025 accreditation.
• Ensure all aspects of ISO 17025 , CLIA, CAP or GLP standards and regulations are met. Examples include:
  • Impartiality – objectivity and conflicts of interest do not exist or are resolved as not to adversely influence subsequent activities
  • Complaint handling – any expression of dissatisfaction by a person or organization to the GeMs businessunit is documented and addressed in a timely and effective manner
• Interlaboratory and intralaboratory comparisons and proficiency testing are routinely performed and monitored for adverse influence on subsequent activities
• Management Review
  • As designated Management Representative for the business unit, perform Management Review as defined by EBDI’s Quality System
  • Define and communicate Quality Goals and Objectives to the business unit and ensure they are achieved
• Continuous Improvement
  • Sources for nonconformities (e.g., nonconformances, audit observations) are documented, investigated for root cause and appropriate corrective/preventive actions are identified and completed in a timely fashion.
  • Manage and participate in periodic audits to ensure that the quality system is effective.
  • Manage external inspections and audits.
  • Maintain Nonconformance/Corrective and Preventative action log and facilitate the completion of these actions.
  • Analyze trends in Nonconformance, Corrective and Preventative actions and present trends to the management team.
  • Maintain the list of Continuous Improvements
• Equipment Management
  • Identify appropriate calibration provider, coordinate calibration service, and resolve problems with instrument calibration.
  • Oversee the annual maintenance service for company-wide equipment. ·
• Document Control
  • Oversee the documentation, archiving and distribution of company-wide procedures and laboratory work instructions.
  • Collaborate with manager(s) to identify training gaps.
  • Maintain organization of Quality System documents ensuring ease of retrieval
• Perform tasks as required to maintain all standard accreditations and as directed by Executive Management
• Safety
  • Conducts inspections to ensure a safe environment and compliance with safety rules and standards.
  • Ensure Safety Data Sheets for all hazardous materials are current and accessible to users of the materials.
  • Ensure hazardous and biohazardous waste are disposed in compliance to 29 CFR 1910 and other applicable regulations to the River Falls facility.
  • Ensure appropriate PPE is available and worn by personnel handling hazardous and biohazardous materials.

• Associates or Bachelor degree (life sciences preferred)
• 3+ years experience with accrediting and/or regulatory agencies (e.g., ISO, CLIA, CAP, GLP).
• Demonstrated Quality Management experience with proactive, mentoring approach to quality culture
• Possess excellent communication and writing skills

This is for a Full-time position which includes:

• Excellent Full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Business Hours: Monday- Friday, 8:00 AM- 5:00 PM

To learn more about Eurofins, please explore our website www.eurofinsus.com.

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

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