Lead Data Reviewer (Fort Worth, TX) job opportunity at Smith+Nephew.

Home Jobs In United States Of America Tag: TX) Lead Data Reviewer (Fort Worth, TX) position at Smith+Nephew


DatePosted 17 Days Ago bot
Smith+Nephew Lead Data Reviewer (Fort Worth, TX)
Experience: 5-years
Pattern: full-time
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loacation Fort Worth, United States Of America
loacation Fort Worth....United States Of America

Lead Data Reviewer (Fort Worth, TX) 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. What will you be doing? 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 What will you need to be successful? 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 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 Skills Experience with regulatory inspections and audits Strong written and verbal communication skills Experience supporting stability programs and method validation Working Conditions 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 ( https://www.smith-nephew.com/). 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!   #LI-ON-SITE Smith+Nephew 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. Stay connected by joining our Talent Community . We're more than just a company - we're a community! Follow us on L inkedIn to see how we support and empower our employees and patients every day.    Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer.    

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