Technical Quality Specialist - Eurofins PSS Insourcing Solutions, LLC

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.

Position Summary:

The Technical Quality Specialist supports the Quality Manager and Business Unit in the maintenance of the quality system through document organization, record storage,   tracking of quality metrics, as well as other tasks in support of ISO 17025 Accreditation, WDNR Accreditation, DEA Registration, and FDA Registration. 

Authority:

The Technical Quality Specialist receives sufficient authority from, and is accountable to, the Eurofins SF Analytical Quality Manager, or appointed designate, for the successful completion of assigned duties and responsibilities and has the authority to take action necessary to carry out the duties and responsibilities of this position and to identify the occurrence of departures from the quality system or from the procedures for performing tests and/or calibrations, so long as such action does not deviate from established company guidelines, is consistent with sound technical and business judgment, and follows the practices of the laboratory.

Essential Duties and Responsibilities Include:

1. Assist laboratory with calibration qualifications of thermometers, ovens, HPLCs, GC’s, UV/Vis, and other instrumentation as necessary.
2. Maintain record storage system for ready access to documents including records retention and Part 11 compliance for select data, reporting that must comply with 21 CFR
3. Assist in maintenance of controlled document system by monitoring for expiring documents and forecasting reviews when needed.
4. Offers feedback on review and revisions of controlled documents relating to the quality system.
5. Assist editors in revisions of other laboratory controlled documents.
6. Maintains master laboratory equipment list, ensuring that all internal and external calibrations are current.
7. Assist in managing approval of vendors, maintaining approved vendor list, including subcontract laboratories.
8. Assist in determining proficiency testing schemes for all testing on accreditation scopes and tracking results.
9. Assign log numbers and add to log for Non-Conformances, CAPAs and OOSs.
10. Assist in review of Non-Conformances, CAPAs and OOSs for appropriate actions taken, track for trends.
11. Coordinates sampling and testing of deionized water system as per schedule.
12. Performs statistical and mathematical calculations to determine uncertainty of testing.
13. Review data, chromatograms, testing results for compendia (USP, FCC, ACS) testing that requires cGMP compliance.
14. Maintain training records of staff.
15. Performs other duties as assigned which may include occasional overnight travel to other Eurofins sites and/or for specialized training

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.

• B.S. in Chemistry or science related field
• At least one year experience in an ISO 17025 laboratory.
• At least one year experience with compliance to 21 CFR Part 11 (cGMP) and/or GLP. 
• Experience in operation and maintenance of HPLCs, UV/Vis, GC, or other laboratory instruments.
• Experience operating GC, HPLC, FTIR, AA and other related equipment
• Familiarity with GLP/GMP guidelines for analytical testing.
• Knowledge of WiDNR, ISO 17025 and related standards

What we offer:

• 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

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