
Pharmaceutical Packaging Supervisor with expertise in GMP compliance and team leadership. Skilled in quality assurance and training personnel, fostering a culture of excellence and compliance in manufacturing and packaging operations.
• Reviewed production batch records for compliance with cGMPs, SOPs, and GDP requirements at all stages of manufacturing.
• Performed QA release and approval of semi-finished materials in ERP system (SAP).
• Triaged unscripted manufacturing events and partner with Production leadership to develop forward processing plans.
• Provided on-floor Quality Assurance oversight of manufacturing and packaging operations to ensure compliance with all internal and regulatory requirements.
• Reviewed and approved planned and unplanned maintenance activities.
• Reviewed and approved electronic batch record recipes and changes to ensure procedural compliance.
• Authored and approved SOPs and Forms in D2.
• Qualified T3 trainer.
• Managed commercial and R&D stability programs to establish and monitor shelf life for sterile injectable pharmaceutical products.
• Maintained stability chambers within validated environmental conditions and coordinated maintenance activities for all stability chambers.
• Authored stability studies, maintained samples throughout defined hold periods, and inspected samples at designated time points.
• Supported preparation of Annual Product Reviews (APR).
• Prepared stability reports analyzing sample conditions to establish or adjust product expiration dating, packaging configurations, and storage conditions.
• Initiated, wrote, and completed Manufacturing investigations.
• Supervised 30+ direct report operators across multiple pharmaceutical packaging lines and sterile manufacturing lines.
• Directed all personnel activities, including hiring, training, performance reviews, disciplinary actions, and merit recommendations.
• Trained and qualified packaging operators on equipment operation, cGMP compliance, and accurate documentation.
• Served as Subject Matter Expert for packaging operations, providing guidance on CAPA investigations, process improvements, and technical questions from cross-functional teams.
• Oversaw equipment modifications and upgrades, supporting qualification and operational readiness activities.
• Supported the startup of two new packaging lines for new products by helping design room layout and process flow, coordinating materials, equipment, and personnel.
• Managed daily store operations and created weekly staff schedules.
• Interviewed, hired and trained associates to comply with company policies and procedures.
• Supervised team performance, conducted reviews, and issued corrective actions to maintain operational standards.
• Attained expert level of product knowledge, becoming go-to person for major sales and vendor negotiations.
• Partnered with regional management team for annual budgeting and purchasing.
• Managed day-to-day operations, ensuring quality and customer satisfaction.
• Trained and mentored new employees to maximize team performance.
• Drove excellent customer service through coaching, role modeling and incorporating customer feedback to reinforce and improve quality of service.
• Recruited and interviewed candidates, providing input on hiring decisions.
• Oversaw product ordering and inventory to ensure adequate stock and minimize waste.
GMP Compliance
Quality Assurance
Manufacturing & Packaging Operations
Team Leadership & Training