Lead Data Reviewer (Fort Worth, TX)

Smith+Nephew•Fort Worth, TX

1d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Lead Data Reviewer is responsible for the accurate and compliant review of laboratory data generated during pharmaceutical testing. This role ensures data integrity, adherence to cGMP/GLP requirements, and compliance with regulatory standards (FDA, ICH). The reviewer plays a critical role in maintaining product quality and supporting regulatory submissions and audits.

Requirements

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline
5+ years of experience in a pharmaceutical, biotech, or regulated laboratory environment (experience level may vary by role)
Strong understanding of cGMP, GLP, FDA, and ICH guidelines
Hands-on experience reviewing analytical data and laboratory documentation
Familiarity with laboratory instruments and computerized systems (e.g., LIMS)
Excellent attention to detail and strong analytical skills
Ability to work independently and manage multiple priorities
Knowledge of data integrity guidance and electronic data systems

Nice To Haves

Experience with regulatory inspections and audits
Strong written and verbal communication skills
Experience supporting stability programs and method validation

Responsibilities

Review and verify laboratory raw data, analytical results, calculations, and reports for accuracy, completeness, and compliance with cGMP/GLP requirements
Provide off-shift leadership by indirect reports
Lead special projects and key contributor to anticipated LIMS expansion and upgrades
Ensure data integrity principles (ALCOA+) are consistently applied
Review analytical testing data including (but not limited to): HPLC Biologic Assays Dissolution Stability studies Wet chemistry and microbiological testing
Identify discrepancies, deviations, out-of-specification (OOS), and out-of-trend (OOT) results and ensure appropriate documentation and investigation
Provide oversight of the laboratory OOS, OOT investigations.
Collaborate with laboratory analysts, QA, and management to resolve data issues
Ensure laboratory documentation follows approved SOPs, protocols, and regulatory guidelines
Support batch release activities and regulatory submissions
Participate in internal and external audits and inspections
Maintain compliance with data integrity, documentation, and record retention requirements