Analytical Data Review Scientist

Eurofins USA
Published
January 1, 2021
Location
Indianapolis, IN
Category
Job Type

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

Data Reviewer responsibilities include, but are not limited to, the following:

  • Perform review of routine and non-routine analytical data generated using techniques such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration to support early phase pharmaceutical small to medium molecules with pre-set timelines
  • Interact with laboratory staff to ensure all data review are appropriately and efficiently corrected and documented
  • Assist with technical report writing and training of laboratory personnel
  • Responsible for ensuring integrity of laboratory data & perform mathematical calculations as part of data review
  • Maintain the highest level of proficiency in terms of those duties and responsibilities as required by auditors/data reviewers
  • Perform independent laboratory data audit to ensure continuous GMP/GLP compliance standards in all areas of responsibility, as appropriate
  • Recognize errors, identify root causes, and implement process improvements
  • Assist with data integrity of analytical data for pharmaceutical small to medium molecules

Qualifications

The ideal candidate would possess:   

  • Good understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends
  • Previous experience conducting, analyzing, and reviewing data for analytical methods such HPLC, UPLC, Karl Fisher, Dissolution, and Multi-product/ multi wavelength methods
  • Good knowledge of three main pharmacopoeias (Japanese; JP, US; USP and European; Ph. Eur.) and ICH guidelines related to pharmaceutical oral solid dosage & parenteral drug testing
  • Previous experience in Analytical Development, Quality Control, or Quality Assurance
  • Understanding of experimentation/data analysis using Empower software and familiarity with ELN (Electronic Notebook)
  • Excellent communication (oral and written), attention to detail and experience interacting with people from a wide range of skill levels
  • Strong client service skills, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment.
  • Strong computer, scientific, and organizational skills.

Basic Minimum Qualifications:

  • Bachelor's degree in analytical chemistry, biochemistry, chemistry or other related degree concentration, or equivalent directly related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
  • At least five years’ experience in laboratory chromatography analyses, Quality, Regulatory, or related experience to support pharmaceutical oral solid dosage & parenteral drug product/substance testing
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is full-time, M-F 8a.m.-5p.m., with overtime as needed.  Candidates currently living in a commutable distance to Indianapolis, IN 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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