Lead Data Reviewer; Fort Worth, TX

Lead Data Reviewer (Fort Worth, TX)

Life Unlimited. At Smith+Ne...

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.

• Review and verify laboratory raw data, analytical results, calculations, and reports for accuracy, completeness, and compliance with cGMP/GLP requirements
• Provide off-shift leadership byindirect 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

• 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

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

• Laboratory and office-based environment
• May require extended periods of data review and computer use
• Occasional overtime to support production timelines or regulatory deadlines

You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ().
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands‑On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

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Smith+Ne... provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.