Eurofins - West Point, PA

posted 7 days ago

Full-time - Entry Level
West Point, PA
Professional, Scientific, and Technical Services

About the position

The Technical Writer at Eurofins Lancaster Laboratories PSS will be responsible for supporting the deviations management team by investigating laboratory deviations, ensuring compliance with regulations, and providing technical support to laboratory staff. The role involves authoring reports, reviewing data audits, and ensuring adherence to compliance-driven timelines while supporting laboratory operations and investigations.

Responsibilities

  • Operate as part of a deviations management team
  • Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented
  • Review data audits
  • Author reports as needed
  • Ensure investigations adhere to the compliance-driven timeline
  • Provide quality and technical support to a team of Laboratory Managers, Data Analysts, and Laboratory Technicians
  • Ensure compliance in the laboratory in accordance with cGMPs, GLPs, international regulations, guidelines, and policies/procedures
  • Direct technical support of the assays performed in the biochemistry, virology, and/or chemistry laboratories
  • Support key projects for Laboratory Operations aimed at elevating compliance, assay robustness, and performance of the laboratories
  • Support laboratory investigations including identification of root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report

Requirements

  • Degree in Chemistry, Biology, or Biochemistry is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
  • For candidates with a Bachelor's degree, a minimum of 3 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting
  • Experience Troubleshooting Laboratory Deviations
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Nice-to-haves

  • Laboratory background (Biochem, Micro, Chem, Virology, etc.)
  • Strong computer, scientific, and organizational skills
  • Excellent communication (oral and written)
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
  • 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
  • Technical writing expertise preferred

Benefits

  • Comprehensive medical coverage
  • Life and disability insurance
  • 401(k) with company match
  • Paid holidays and vacation
  • Personal days
  • Dental and vision options
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