Job Description

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

Qualifications

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

Additional Information

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.