GMP Analytical Chemistry Data Reviewer

Eurofins PSS Insourcing Solutions; New York (NY); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

Life & Disability Insurance

401(k) plan with company match

Paid Time Off

Job summary

Eurofins USA PSS Insourcing Solutions seeks an Analytical Chemistry Data Reviewer to audit GMP laboratory data and documentation for compliance with established procedures and regulatory standards. A strong chemistry background and experience in reviewing analytical data under GMP are essential.

Responsibilities include data/gdp review, logbook validation, chain of custody, audit-trail checks, cross-training across lab functions, and collaboration with teams to ensure timely, compliant testing

Qualifications

• GMP data review experience required.
• Experience with analytical data review and documentation.
• Ability to follow GDP and regulatory requirements.

Responsibilities

• GMP Data & Documentation Review
• Verify logbooks and entries for accuracy and GDP adherence
• Confirm sample chain of custody throughout testing
• Review audit trails for procedural compliance
• Cross-training across laboratory testing functions
• Maintain proficiency in analytical techniques and processes
• Provide hands-on testing support when needed
• Collaborate to resolve data annotations and discrepancies
• Ensure safety and regulatory compliance

Skills

HPLC/UPLC

UV-Vis spectroscopy

ELISA

MCE

iCIEF

Education

Bachelor’s degree in Chemistry or Life Sciences

2+ years of cGMP experience

Direct GMP data review experience in industry

Job description

Company Description

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. Life at Eurofins is a meritocracy, where people are empowered to make decisions and are rewarded for their success, allowing them to advance quickly. Become your most extraordinary self with support and development throughout your career.

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

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. Candidates currently living within a commutable distance of Rensselear, New York, are encouraged to apply

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

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