GMP Analytical Chemistry Data Reviewer

Eurofins USA PSS Insourcing Solutions; City of Rensselaer (NY); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Medical Coverage

Dental & Vision

Life & Disability Insurance

401(k) Retirement Plan

Paid Time Off

Competitive hourly compensation

Job summary

Eurofins USA PSS Insourcing Solutions is seeking an Analytical Chemistry Data Reviewer in Rensselaer, NY. The role focuses on reviewing GMP laboratory data and documentation to ensure data integrity and regulatory compliance.

Responsibilities include data and logbook review, GDP adherence, and collaboration with laboratory personnel to ensure timely testing. Requires a chemistry background and 2+ years of cGMP experience in industry.

Qualifications

• Bachelor’s degree in Chemistry, Life Sciences, or related scientific field.
• 2+ years of cGMP experience in a regulated laboratory environment.
• Direct experience reviewing GMP data in an industrial setting.

Responsibilities

• GMP Data & Documentation Review: review GMP data and documentation for compliance with procedures and GDP standards.
• Cross-Training & Laboratory Support: participate in cross-training and provide hands-on testing support as needed.
• Communication & Issue Resolution: resolve data annotations, discrepancies, or corrections with testing personnel.
• Good Documentation Practices (GDP): document activities in logbooks, notebooks, and electronic systems following GDP.
• Safety & Compliance: conduct safety and compliance walkthroughs and complete required trainings.

Skills

HPLC/UPLC

UV-Vis spectrophotometry

ELISA

MCE

iCIEF

GMP data review

Education

Bachelor’s degree in Chemistry or Life Sciences

Job description

Job Description

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.

Key Responsibilities

GMP Data & Documentation Review

• 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

Cross-Training & Laboratory Support:

• May be required to participate in cross-training opportunities across laboratory testing functions to broaden technical knowledge and enhance operational flexibility.
• Develop and maintain proficiency in applicable analytical testing techniques and laboratory processes as assigned.
• May be required to provide occasional hands-on laboratory testing support during periods of increased workload, staffing needs, or business priorities, when qualified and appropriately trained.
• Collaborate with laboratory personnel to ensure timely completion of testing activities while maintaining compliance with GMP, GDP, safety, and regulatory requirements.

Communication & Issue Resolution

• Collaborate with testing personnel to resolve data annotations, discrepancies, or corrections
• Partner with laboratory teams to support compliance and continuous improvement initiatives

Good Documentation Practices (GDP)

• Accurately document activities in logbooks, notebooks, and electronic systems following GDP expectations

Safety & Compliance

• Conduct laboratory safety and compliance walkthroughs and document observations as required
• Complete all required safety, procedural, and refresher trainings on schedule

  Qualifications

  Qualifications

  Education & Experience

  • 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

  Technical Skills

  • Hands-on experience with HPLC/UPLC and UV‑Vis spectrophotometry
  • Experience with ELISA, MCE, and/or iCIEF preferred
  • Proven ability to process and review quantitative liquid chromatography data

  Physical Requirements

  • Able to meet physical requirements, including lifting 25 lbs., prolonged standing or walking, pushing/pulling equipment, and bending or reaching for supplies

  Additional Requirements

  • 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

  Additional Information

  Position is Full Time, Monday-Friday, First Shift, Monday through Friday from 8am-4:30pm.

  Rensselear, New York,

  Excellent full-time benefits include:

  • Medical Coverage: Comprehensive medical insurance options
  • Dental & Vision: Full dental and vision coverage available
  • Life & Disability Insurance: Employer-sponsored plans
  • Retirement: 401(k) plan with company match
  • Paid Time Off: Vacation days, paid holidays, and additional PTO options
  • Compensation: $26.25 - $30.00 per hour

  LinkedIn: #LI-EB1

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

  Compensation: $26-$26