Analytical Sciences GMP Data Reviewer

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

• Bachelors 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  UVVis 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.

Remote Work :

No

Employment Type :

Full-time