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Biochemist - Deviation Investigations Support

3 months ago

West Point, United States Eurofins USA PSS Insourcing Solutions Full time
Job DescriptionJob DescriptionCompany 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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It 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. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Responsibilities include, but are not limited to, the following:

  • Operate as part of a deviation’s management, change control and assay monitoring technical team.
  • Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented by identifying root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report
  • Review data audits and author reports as needed
  • Ensure investigations adhere to the compliance-driven timeline
  • Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures.
  • Qualification and Validation studies
  • Providing analytical change management support for Biochemistry, Chemistry, Virology, and Supplies Inspection testing labs (LOCV)
  • Technical oversight and execution of Biochemistry quality control assays
  • Support assay throughout the process including writing protocols, executing assay methods, and writing final reports
  • General lab duties (includes organizing supplies/media, removal of Biohazardous waste cleaning, stocking, cold room 5S, etc.)
Qualifications

The ideal candidate would possess :

  • Ability to learn quickly, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Attentiveness to detail
  • Experience with GMP documentation practices and a strong understanding of GMP practices in the instructions, and comply with company policies
  • Technical writing expertise
  • Root Cause Analysis expertise preferred
  • Project Management, Change Execution Management and Team Leadership experience in a Quality function
  • Demonstrated self-starter with capability to develop innovative solutions to challenges

Basic Minimum Qualifications :

  • BS degree in Biochemistry, Biology, Cell Biology or related discipline is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
  • 3+ years in science industry experience
  • Experience Troubleshooting Laboratory Deviations
  • Experience in change controls
  • Experience in in execution of assay monitoring
  • Authorization to work in the United States indefinitely without restriction or sponsorship


Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00 pm  with overtime as needed.  Candidates currently living within a commutable distance of West Point PA 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
  • Yearly goal-based bonus & eligibility for merit-based increases

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.