<p>SUMMARY:</p> <p>The Packaging Team Lead is responsible for compliance with current good manufacturing practices (cGMP) and is the subject matter expert on packaging operations, including batch record reviews, production schedules, equipment, packaging line operations, safety, and standard operating procedures (SOPs).</p> <p>RESPONSIBILITIES:</p> <ul> <li>Responsible for ensuring equipment and rooms are set up properly and accurately documented in correct logbooks. </li><li>Trains and leads new and existing packaging operators on job functions, including (SOPs) and cGMP. </li><li>Set up, clean, and operate packaging rooms and equipment. </li><li>Troubleshoot and problem-solve issues with packaging operations, packaging line, packaging room, related cGMP, outputs, SOPs, and batch records. </li><li>Provide support and/or knowledge for change controls, system investigation reports (SIRs), and SOPs. </li><li>Conduct batch record reviews for accuracy and completeness. </li><li>Work with department leaders on process improvements and ongoing continuous improvement opportunities. </li><li>All other tasks as requested or assigned. </li></ul> <p>QUALIFICATIONS AND REQUIREMENTS:</p> <ul> <li>High School Diploma or GED equivalent required. </li><li>4+ years of experience in an FDA or cGMP manufacturing facility required. </li><li>Team Lead or demonstrated success in leading through influence preferred. </li><li>Basic computer skills required. </li><li>Experience with Master Control, Microsoft Suite (Excel, Word, Outlook), and Microsoft Dynamics 365 preferred. </li></ul>