JOB REQUIREMENTS: Company Description 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. 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: * Assist laboratory with calibration
qualifications of thermometers, ovens, HPLCs, GC\'s, UV/Vis, and other
instrumentation as necessary. * 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 *
Assist in maintenance of controlled document system by monitoring for
expiring documents and forecasting reviews when needed. * Offers
feedback on review and revisions of controlled documents relating to the
quality system. * Assist editors in revisions of other laboratory
controlled documents. * Maintains master laboratory equipment list,
ensuring that all internal and external calibrations are current. *
Assist in managing approval of vendors, maintaining approved vendor
list, including subcontract laboratories. * Assist in determining
proficiency testing schemes for all testing on accreditation scopes and
tracking results. * Assign log numbers and add to log for
Non-Conformances, CAPAs and OOSs. * Assist in review of
Non-Conformances, CAPAs and OOSs for appropriate actions taken, track
for trends. * Coordinates sampling and testing of deionized water
system as per schedule. * Performs statistical and mathematical
calculations to det To view the full job description please use the link
below.
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