GMP Analytical Chemistry 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.

Responsibilities

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; Participate in cross-training opportunities across laboratory testing functions as required; Provide occasional hands-on laboratory testing support during periods of increased workload when qualified; Collaborate with laboratory personnel to ensure timely completion of testing activities while maintaining compliance; Resolve data annotations, discrepancies, or corrections with testing personnel; Partner with laboratory teams to support compliance and continuous improvement initiatives; Conduct laboratory safety and compliance walkthroughs and document observations; Complete all required safety, procedural, and refresher trainings on schedule

Requirements

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; Hands-on experience with HPLC/UPLC and UV-Vis spectrophotometry; Ability to meet physical requirements, including lifting 25 lbs., prolonged standing or walking, pushing/pulling equipment, and bending or reaching for supplies; 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

Nice to have

ELISA; MCE; iCIEF

Benefits

Comprehensive medical insurance options; Full dental and vision coverage; Employer-sponsored life and disability insurance; 401(k) plan with company match; Vacation days, paid holidays, and additional PTO options