Lead Data Reviewer (Fort Worth, TX)

<p><b>Lead Data Reviewer (Fort Worth, TX)</b></p><p></p><p><b>Life Unlimited. </b>At Smith&#43;Nephew we design and manufacture technology that takes the limits off living.<b><span>    </span></b></p><p></p><p>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.</p><p></p><p></p><p><b>What will you be doing?</b></p><ul><li><p>Review and verify laboratory raw data, analytical results, calculations, and reports for accuracy, completeness, and compliance with cGMP/GLP requirements</p></li><li><p>Provide off-shift leadership by indirect reports</p></li><li><p>Lead special projects and key contributor to anticipated LIMS expansion and upgrades     </p></li><li><p>Ensure data integrity principles (ALCOA&#43;) are consistently applied</p></li><li><p>Review analytical testing data including (but not limited to):</p><ul><li><p>HPLC</p></li><li><p>Biologic Assays</p></li><li><p>Dissolution</p></li><li><p>Stability studies</p></li><li><p>Wet chemistry and microbiological testing</p></li></ul></li><li><p>Identify discrepancies, deviations, out-of-specification (OOS), and out-of-trend (OOT) results and ensure appropriate documentation and investigation</p></li><li><p>Provide oversight of the laboratory OOS, OOT investigations.</p></li><li><p>Collaborate with laboratory analysts, QA, and management to resolve data issues</p></li><li><p>Ensure laboratory documentation follows approved SOPs, protocols, and regulatory guidelines</p></li><li><p>Support batch release activities and regulatory submissions</p></li><li><p>Participate in internal and external audits and inspections</p></li><li><p>Maintain compliance with data integrity, documentation, and record retention requirements</p></li></ul><p></p><p><b>What will you need to be successful?</b></p><ul><li><p>Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline</p></li><li><p>5&#43; years of experience in a pharmaceutical, biotech, or regulated laboratory environment</p></li><li><p>Strong understanding of cGMP, GLP, FDA, and ICH guidelines</p></li><li><p>Hands-on experience reviewing analytical data and laboratory documentation</p></li><li><p>Familiarity with laboratory instruments and computerized systems (e.g., LIMS)</p></li><li><p>Excellent attention to detail and strong analytical skills</p></li><li><p>Ability to work independently and manage multiple priorities</p></li><li><p>Knowledge of data integrity guidance and electronic data systems</p></li></ul><p></p><p><b>Preferred Skills</b></p><ul><li><p>Experience with regulatory inspections and audits</p></li><li><p>Strong written and verbal communication skills</p></li><li><p>Experience supporting stability programs and method validation</p></li></ul><p></p><p><b>Working Conditions</b></p><ul><li><p>Laboratory and office-based environment</p></li><li><p>May require extended periods of data review and computer use</p></li><li><p>Occasional overtime to support production timelines or regulatory deadlines</p></li></ul><p></p><p></p><p></p><p><b>You Unlimited. </b>We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.    </p><p></p><ul><li><p><b>Inclusion and Belonging- </b><span>Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( </span><a href="https://www.smith-nephew.com/%29." target="_blank"><span>https://www.smith-nephew.com/).</span></a></p></li><li><p><b>Your Future:</b><span> 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  </span></p></li><li><p><b>Work/Life Balance:</b><span> Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  </span></p></li><li><p><b>Your Wellbeing:</b><span> Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500&#43; annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program </span></p></li><li><p><b>Flexibility:</b><span> Hybrid Work Model (For most professional roles)  </span></p></li><li><p><b>Training:</b><span> Hands-On, Team-Customized, Mentorship  </span></p></li><li><p><b>Extra Perks:</b><span> Discounts on fitness clubs, travel and more!  </span></p></li></ul><p></p><p></p><p><b>#LI-ON-SITE </b></p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left">Smith&#43;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.</p><div><p style="text-align:inherit"></p><p style="text-align:left">Stay connected by joining our <a href="https://smithnephew.wd5.myworkdayjobs.com/External/page/4ba17039009510002b17ea5e89c40000" target="_blank">Talent Community</a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span><span>We&#39;re</span><span> more than just a company - </span><span>we&#39;re</span><span> a community! Follow us on <a href="https://www.linkedin.com/company/smith-&amp;-nephew/" target="_blank">L</a></span></span><a href="https://www.linkedin.com/company/smith-&amp;-nephew/" target="_blank">inkedIn</a><span><span> to see how we support and empower our employees and patients every day. </span> </span></p></div><div><div><p style="text-align:inherit"></p><p style="text-align:left"><span><span>Check us out on <a href="https://www.glassdoor.com/Overview/Working-at-Smith-and-Nephew-EI_IE10233.11,27.htm" target="_blank">Glassdoor</a> for a glimpse behind the scenes and a sneak peek into </span></span><b><span>You</span><span>. </span><span>Unlimited</span><span>.</span></b><span><span>, life, culture, and benefits at S&#43;N.</span></span></p><p style="text-align:inherit"></p></div><div><p style="text-align:left"><span><span>Explore our <a href="https://www.smith-nephew.com/en/" target="_blank">website</a></span></span><span><span> and learn more about our mission, our team, and the opportunities we offer.</span></span><span> </span></p></div></div><div><p style="text-align:inherit"><span> </span></p></div>