Analytical Sciences GMP Data Reviewer at Eurofins | NY, US | Rezi

Analytical Sciences GMP Data Reviewer at Eurofins

Analytical Sciences GMP Data Reviewer

Eurofins · NY, US

1 weeks ago

Analytical Sciences GMP Data Reviewer

Eurofins · NY, US

11 days ago
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About the Role

The Analytical Chemistry Data Reviewer is responsible for reviewing GMP laboratory data and documentation to ensure compliance with established procedures, data integrity standards, and regulatory requirements. This role requires a strong chemistry background and experience reviewing analytical data in a GMP-regulated environment.

Responsibilities

  • Review GMP data generated by laboratory personnel to ensure compliance with approved procedures
  • Verify logbook and documentation entries for accuracy, completeness, and adherence to GDP standards
  • Confirm the sample chain of custody throughout the testing lifecycle
  • Review audit trails to ensure actions align with procedural requirements and timelines
  • Participate in cross-training opportunities across laboratory testing functions
  • Develop and maintain proficiency in applicable analytical testing techniques and laboratory processes
  • Provide occasional hands-on laboratory testing support during periods of increased workload, staffing needs, or business priorities
  • Collaborate with laboratory personnel to ensure timely completion of testing activities while maintaining compliance with GMP, GDP, safety, and regulatory requirements
  • Collaborate with testing personnel to resolve data annotations, discrepancies, or corrections
  • Partner with laboratory teams to support compliance and continuous improvement initiatives
  • Accurately document activities in logbooks, notebooks, and electronic systems following GDP expectations
  • Conduct laboratory safety and compliance walkthroughs and document observations
  • Complete all required safety, procedural, and refresher trainings on schedule

Requirements

  • Bachelor’s degree in Chemistry, Life Sciences, or a related scientific field
  • 2+ years of cGMP experience in a regulated laboratory environment
  • Direct experience reviewing GMP data in an industrial setting
  • Proven ability to process and review quantitative liquid chromatography data
  • Able to meet physical requirements, including lifting 25 lbs., prolonged standing or walking, pushing/pulling equipment, and bending or reaching for supplies
  • Ability to learn new processes and manage multiple tasks simultaneously
  • Ability to follow instructions and comply with company policies and regulatory requirements
  • Authorized to work in the United States indefinitely without sponsorship

Skills

  • HPLC/UPLC
  • UV‑Vis spectrophotometry
  • ELISA
  • MCE
  • iCIEF

Location

  • United States

Work Type

  • Full Time
  • First Shift

Experience Level

  • 2+ years of cGMP experience

Education Level

  • Bachelor’s degree in Chemistry, Life Sciences, or a related scientific field

Salary/Compensations

  • $26.25 - $30.00 per hour

Benefits

  • Comprehensive medical insurance options
  • Full dental and vision coverage available
  • Employer-sponsored Life & Disability Insurance plans
  • 401(k) plan with company match
  • Vacation days, paid holidays, and additional PTO options

About the Company

  • At Eurofins PSS, we work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust us with their mission-critical testing.
  • For 20 years, our international network of teams have served clients at their sites, across 20 countries.
  • PSS® is part of Eurofins Scientific, an international life sciences company, providing a unique range of analytical testing services across multiple industries, through a network of over 950 laboratories in 60 countries, and c.a. 63,000 employees.

Equal Opportunity

  • Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.