Analytical Sciences GMP Data Reviewer
Rensselaer, NYFull-time$26.25–30/hrPosted 1w agoStill listed 3 days ago
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Job overview
The Analytical Chemistry Data Reviewer reviews GMP laboratory data and documentation for compliance with procedures, data integrity standards, and regulatory requirements. The role also supports laboratory teams through cross-training, occasional hands-on testing when qualified and trained, issue resolution, and compliance initiatives. Candidates need a scientific bachelor’s degree, cGMP laboratory experience, and direct GMP data-review experience.
Skills & qualifications
Skills
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Benefits
Full 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.
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.
- 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.
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