QC Data Reviewer
Eurofins

Philadelphia, Pennsylvania

This job has expired.



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 generatedtotal revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Responsible for reviewing and approving of all GMP data generated by QC and contract testing organizations, including paper and electronic data. Working in the data review team, this person will collaborate with laboratory management and QA to ensure data integrity and all GMP/GDP and regulatory requirements are met.

Main Responsibilities:

  • Review laboratory records and test results, both paper-based and in electronic format (i.e. LIMS), including audit trails, for completeness and accuracy
  • Ensure the assay records and related information are compliant to test method, procedures, specifications, cGMP, and internal SOP requirements and scientifically sound
  • Communicates with analysts and laboratory managers to proactively address quality impacting issues
  • Provide support as required to address data related issues internally or in collaboration with other departments as a member of a cross-functional team.
  • Performs other duties as assigned
Effort allocation:

70%
  • Review internal GMP assay records and results and electronic data, as well as contract testing lab's reports, records, and data to support lot release and other QC studies
  • Review audit trails of instruments
30%
  • Work with internal and external stake holders to improve data integrity by strengthening data review process.
  • Provide support to audit and inspection and management to address issues identified during data review

Qualifications
  • BS, MS or higher degree on biological, chemical sciences, or related discipline
  • 8+ years for BS, 3+ years for MS, 2+years for PhD, of related experience in the Pharmaceutical/Biotech industry working in a GMP/regulated environment
  • Previous GLP/GMP data review experience
  • Thorough knowledge of virology, microbiology, and compendial assays, such as viral safety, bioburden, endotoxin, growth promotion, pH, Osmolality, viral titer, impurity and potency testing.
  • General knowledge of other analytical assays is a plus
  • Experience in analytical instrument audit trail review preferred
  • Experience in data review in LIMS preferred

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Philadelphia, PAare encouraged to apply.
  • 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.


This job has expired.

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