Senior Quality Specialist - Richmond - job 635418

Eurofins

Date: 02/22/2021

City: Richmond, Virginia

Employment type: Full-time

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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.


In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.


In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.




Job Description




Job Description



  • Coordinate, schedule, and support internal and external audits, provide support for inspections, incidents, deviations, and CAPAs in accordance with current quality management system process.

  • Maintain, review, and submit all Trackwise records related to CAPAs and Events. 

  • Initiate, write, and lead root cause analysis investigations and implement corrective and preventive actions in laboratory test labs (analytical and physical), with guidance and in collaboration with laboratory subject matter experts.

  • Consult on development of quality improvements and recommend solutions as applicable.

  • Prepare diagnostic actions plans to troubleshoot analytical system failures or trends in statistical process control data

  • Communicate to Group Leaders, Lab Manager & Site Director in addition to client stakeholders laboratory status, issues impacting results delivery and quality, and raise risks and opportunities to Quality Team in a timely manner

  • Review laboratory data (smoke, analytical & physical) and assess quality control

  • Monitor and assess statistical process control data and elevate trends or out of control events to Management and/or Client Stakeholders

  • Respond to internal audit observations within 30 days of report receipt identifying planned actions

  • Write and revise SOPs and Work Instructions.  Proactively recommend and participate in process improvement projects. 

  • Coordinate document control. 

  • Coordinate, schedule, and conduct internal audits; prepare for external audits; host external auditors

  • Prepare for external audits; host external auditors

  • Conduct training

  • Generate and track laboratory notebooks and controlled documents




Qualifications




  • A Bachelor’s degree in Regulatory Affairs, Chemistry, or science-related discipline with at least five years of demonstrated experience in quality systems operations.  

  • Knowledge of ISO/IEC 17025, GMP and GLP regulations

  • Experience with the following technologies and test areas:  Gas Chromatography, Liquid Chromatography, Mass Spectrometry, Ion Chromatography, ICP-MS (preferred), Analytical Smoking (preferred), Physical testing (preferred)

  • Demonstrated experience with root cause analysis and Corrective and Preventive Action required.

  • Experience in the audit process.

  • Experience with Track Wise™ 

  • Detailed-oriented with strong analytical and organizational skills.

  • Strong written, verbal and presentation skills along with demonstrated ability to collaborate with others.

  • Demonstrate strong client service skills, teamwork, and collaboration

  • Strong computer, scientific, and organizational skills

  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

  • Authorization to work in the United States indefinitely without restriction or sponsorship



Additional Information




Position is full-time, Monday-Friday 8:00 a.m.-5:00p.m., with overtime as needed.  Candidates currently living in a commutable distance to Richmond, VA are encouraged to apply.


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.





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