Analytical Data Reviewer — Quality, Compliance & Insights

Eagle Analytical Services; Houston (TX); On-site; USD 85,000 - 112,000; Full time

Job summary

Eagle Analytical Services seeks an Analytical Data Review Scientist to analyze and report laboratory data, support quality and compliance, and assist with data management. The role combines analytical chemistry, data analytics, and document control in a regulated pharmaceutical environment.

Responsibilities include reviewing data for cGMP compliance, signing off as author and reviewer, and supporting audits.

Qualifications

• Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related science field.
• Minimum 2 years' experience in a regulated pharmaceutical analytical laboratory, or equivalent.
• Proficiency with analytical instruments (HPLC, UPLC, GC, UV/Vis spectrophotometer) including operation, troubleshooting, and maintenance.
• Experience with LIMS (Empower, EagleTrax) and electronic data review.
• Strong knowledge of cGMP, cGLP, ISO 17025, USP, A2LA, and data integrity principles.
• Experience with laboratory documentation, technical review of analytical data, and OOS/OOT investigations.

Responsibilities

• Review analytical data, chromatographic reports, calculations, and laboratory worksheets for completeness and compliance.
• Electronically sign off on data as author and reviewer per procedures.
• Review OOS and OOT investigations for regulatory and quality compliance.
• Maintain accurate documentation of laboratory activities, SOPs, and forms.
• Write, revise, and review SOPs and forms as required.
• Support audits and safety reviews.
• Participate in investigations and CAPA risk assessments.
• Communicate with staff to address documentation quality and deficiencies.
• Perform routine/non-routine chemical analyses using HPLC, UPLC, GC, and spectrophotometry.
• Process raw data in LIMS and ensure traceability.
• Perform routine testing on samples and meet deadlines.
• Notify supervisors of unexpected results and assist with problem-solving.
• Maintain calibration and maintenance of equipment; report issues.
• Assist across workstations and provide backup support.
• Maintain clean, safe laboratory areas and proper safety practices.
• Generate reports to support operations and timely release of results to clients.
• Provide consultative support to customers on testing methods and results.
• Participate in team discussions to achieve lab goals.
• Stay current with technology, instruments, and regulatory changes in pharmaceutical analytics.
• Assist in training new hires.

Skills

Data analysis

Regulatory knowledge

Communication

Independence

Education

Bachelor's degree in Chemistry or related field

Master's degree preferred

Tools

HPLC

UPLC

GC

UV/Vis spectrophotometer

LIMS: Empower

LIMS: EagleTrax

Job description

Eagle Analytical Services seeks an Analytical Data Review Scientist to analyze and report laboratory data, support quality and compliance, and assist with data management. The role combines analytical chemistry, data analytics, and document control in a regulated pharmaceutical environment.

Responsibilities include reviewing data for cGMP compliance, signing off as author and reviewer, and supporting audits.