Smith+Nephew · 1 day ago
Lead Data Reviewer (Fort Worth, TX)
Fort Worth, TX
Full-time
Hybrid
Senior Level
5+ years expSmith+Nephew is a company that designs and manufactures technology aimed at enhancing quality of life. The Lead Data Reviewer is responsible for the accurate and compliant review of laboratory data generated during pharmaceutical testing, ensuring data integrity and adherence to regulatory standards.
Medical Device
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
Qualification
Required
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
Preferred
Experience with regulatory inspections and audits
Strong written and verbal communication skills
Experience supporting stability programs and method validation
Benefits
401k Matching Program
401k Plus Program
Discounted Stock Options
Tuition Reimbursement
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Medical
Dental
Vision
Health Savings Account (Employer Contribution of $500+ annually)
Employee Assistance Program
Parental Leave
Fertility and Adoption Assistance Program
Hybrid Work Model (For most professional roles)
Hands-On, Team-Customized, Mentorship
Discounts on fitness clubs, travel and more!
Company
Smith+Nephew
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Katerina Dodbiba
SVP, CFO Orthopaedics, Sports Medicine & ENT
Pierre Palassian
SVP, CFO Global Operations, Quality and Regulatory Affairs
Recent News
2025-10-06
2025-10-03
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