
Dedicated professional with a proven track record in cGMP-regulated environments, specializing in team leadership, operational efficiency, and quality assurance. Skilled in maintaining compliance with FDA standards, training employees, and driving process improvements to meet production goals. Known for building collaborative teams and ensuring high-quality outcomes in fast-paced manufacturing settings.
• Lead daily production operations, ensuring safety, quality, and workflow targets are consistently met across multiple packaging processes.
• Provide real-time leadership to associates, coach PAII staff, and reinforce compliance with SOPs, cGMP, and safety expectations.
• Communicate cross-shift updates with previous LL, escalate issues to QA/Supervisors, and ensure smooth operational handoff.
• Review batch records, work orders, and Lot/Exp assignments for accuracy; identify errors, correct discrepancies, and report deviations promptly.
• Oversee and verify equipment challenges, daily checks, calibration reports, and cleaning activities to maintain audit-ready conditions.
• Troubleshoot equipment and process issues, make sound decisions to prevent delays, and coordinate with support teams to maintain production continuity.
• Train associates at the start of each shift, clearly explaining procedures, documenting sign-ins, and verifying job readiness.
• Maintain precise documentation of start/end times, downtime, reconciliation, and finished goods counts, ensuring alignment with BRR and cold storage.
• Conduct end-of-shift TOR verification, confirm normalization times, verify PAII recovery sign-off, and prepare all components/bulk for the next shift.
• Perform 200% checks when required, enforce proper PPE use, and routinely inspect the area to ensure a safe and compliant work environment.
• Collaborate with QA to maintain high-quality packaging standards, ensure accurate documentation, and support continuous improvement initiatives.