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
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
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.