Melissa Lantagne

· Directed the delivery and performance of integrated workplace services, overseeing internal staff, third-party vendors, and suppliers to ensure operational excellence and uninterrupted business operations across GMP and non-GMP environments.

· Built and maintained strategic partnerships with client stakeholders through proactive communication, service excellence, and consistent achievement of contractual service levels and key performance indicators (KPIs).

· Led workplace services operations, including janitorial services, pest control, laboratory, landscaping, non-hazardous waste management, meeting and event support, and other site-wide soft services.

· Managed vendor performance, contract compliance, and procurement activities, ensuring delivery of services met quality standards, regulatory requirements, and client expectations.

· Collaborated with Environmental Health & Safety (EHS), Quality, Procurement, Finance, and Operations teams to support investigations, resolve technical issues, and maintain compliance with GxP, GMP, and safety requirements.

· Championed workplace experience initiatives and employee engagement programs, driving adoption of new processes and technologies to enhance operational efficiency and customer satisfaction.

· Analyzed customer satisfaction data, performance metrics, and service trends to develop corrective action plans and continuous improvement initiatives that strengthened service delivery and client relationships.

· Led, coached, and developed multidisciplinary teams by fostering a culture of accountability, teamwork, safety, and continuous professional growth.

· Lead complex investigations involving quality events, deviations, non-conformances, and compliance issues, ensuring timely resolution, robust root cause analysis, and adherence to regulatory and GMP requirements.

· Author, review, and approve deviation investigations and quality records, ensuring documentation accuracy, completeness, and compliance with established quality standards and regulatory expectations.

· Develop, implement, and oversee Corrective and Preventive Action (CAPA) programs, driving sustainable solutions that enhance compliance, mitigate risk, and reduce recurrence of quality issues.

· Monitor CAPA effectiveness through data analysis, trend monitoring, and key performance indicators (KPIs), providing management with actionable insights and recommendations for continuous improvement.

· Collaborate closely with Site Leadership and cross-functional stakeholders to address quality concerns, implement process improvements, and strengthen the overall Quality Management System.

· Review and approve Standard Operating Procedures (SOPs), protocols, technical reports, and quality system records to ensure regulatory compliance and operational excellence.

· Designed and implemented a comprehensive training matrix and competency assessment program, improving employee proficiency, training compliance, and inspection readiness across multiple departments.

· Serve as the primary Quality Assurance representative for leadership meetings, regulatory inspections, customer audits, and strategic project teams, providing expert guidance and influencing key business decisions.

· Develop and deliver onboarding, GMP, and quality systems training programs, ensuring personnel maintain compliance with regulatory requirements and industry best practices

• Led daily rotations in GMP, CNC, and non-graded areas, ensuring inspection readiness and regulatory compliance
• Made independent decisions on critical GMP matters, collaborating with cross-functional teams for complex issues
• Authorized the placement and removal of Quality Tag Outs, playing a key role in ensuring smooth and compliant equipment transitions during Product Changeovers
• Served as primary QA representative in meetings, audits, and project teams, providing strategic insights and driving decisions with senior leadership
• Mentored cross-functional teams (Manufacturing, QC, Engineering, MSAT, Warehouse), boosting compliance and operational efficiency
• Identified best practices and led initiatives to drive continuous improvement in WH processes, fostering a culture of ongoing enhancement
• Led, mentored, and trained QA Specialists, providing robust development opportunities, promoting accountability, and nurturing a high-performing team
• Conducted thorough reviews and approvals of GMP documents, policies, and quality records, ensuring they meet all GDP, regulatory and compliance standards
• Approved GMP documents, deviations, CAPAs, and CCRs, ensuring regulatory compliance
• Maintained inspection readiness and upheld high-quality standards consistently
• Addressed process gaps and ensured compliance with site procedures, mitigating operational risks
• Proactively handled additional responsibilities, demonstrating flexibility and commitment to organizational goals
• Uphold standard operating procedures and training programs to ensure that all components, raw materials, drug product containers, closures, in-process materials, labeling, and drug products are received and handled in compliance with site protocols

• Lead investigations and apply problem-solving tools as the primary owner or Quality Assurance (QA) Approver to identify and resolve quality issues
• Support the execution and closure of deviations, corrective actions and change controls to address deviations from GMP standards, ensuring compliance and continuous improvement
• Review and approve GMP master documents and executed GMP documents across departments such as Quality Control, Manufacturing, Material Management, Facilities, Engineering, and other teams involved in lot production, ensuring all documents meet regulatory and internal standards
• Take ownership of the generation, inspection, and release of labels, ensuring full compliance with regulatory requirements and quality standards
• Collaborate with Manufacturing and support teams to conduct regular QA walkthroughs, proactively identifying and addressing any issues or non-conformances during the production process
• Review and approve GMP documentation in real time arising from manufacturing activities—such as batch records, forms, logbooks, and work orders—ensuring accuracy and strict adherence to GMP guidelines
• Manage the preparation, distribution, and archival of documentation, ensuring proper organization and compliance with file management systems
• Assist in investigating and resolving quality-related issues, including customer complaints, by working cross-functionally with relevant departments to implement corrective actions
• Actively engaged with clients to address inquiries, resolve complaints, and provide timely solutions

• Successfully managed and delivered multiple projects concurrently, consistently meeting strict deadlines while ensuring high-quality results
• Ensured compliance with industry standards by staying current with relevant guidelines, policies, and regulations impacting QC operations, and implementing them in day-to-day processes
• Contributed to the performance and documentation of environmental monitoring for clean rooms and water systems, ensuring full compliance with Standard Operating Procedures (SOPs)
• Conducted comprehensive Environmental and Utility monitoring, supporting facility validation activities through precise testing and data collection
• Proactively reduced production errors by meticulously monitoring product specifications and identifying process improvements to enhance overall efficiency and quality
• Analyzed and interpreted environmental monitoring data from various manufacturing areas, ensuring adherence to compliance standards and identifying opportunities for optimization

• Maintained a clean, organized, and safe laboratory environment, strictly adhering to best practices for laboratory safety, hygiene, and regulatory requirements
• Conducted routine sampling of raw materials according to established sampling plans and schedules, ensuring accuracy and consistency in data collection
• Assisted in the execution and documentation of environmental monitoring for clean rooms and water systems, ensuring full compliance with Standard Operating Procedures (SOPs)
• Performed microbiological testing with precision and efficiency, ensuring timely delivery of high-quality results in accordance with industry standards
• Conducted detailed visual inspections of incoming raw materials to assess their quality, integrity, and suitability for production
• Utilized appropriate sampling techniques and equipment to collect representative samples for testing, ensuring reliability and accuracy in testing outcomes
• Performed Environmental and Utility monitoring, contributing to the maintenance of facility compliance and operational integrity
• Supported facility validation activities by conducting testing, ensuring all systems met operational and regulatory standards
• Conducted Environmental Monitoring of Aseptic Production areas, ensuring aseptic conditions were maintained at all times
• Analyzed and interpreted environmental monitoring data from various manufacturing areas to ensure compliance and identify areas for improvement
• Ensured accurate labeling and documentation of sampled materials, maintaining thorough records of sample information and batch numbers to support traceability
• Performed microbiological testing, including endotoxin, bioburden, TOC, and conductivity testing for water systems, ensuring compliance with quality and regulatory standards

• Collaborated with cross-functional teams to ensure efficient task completion and strict adherence to cleanroom protocols
• Prioritized tasks effectively, excelling in both independent and team-based work with minimal supervision
• Sanitized cleanroom facilities, focusing on preventing bacterial and fungal contamination while maintaining compliance with EPA and GMP regulations
• Prepared cleaning solutions per exact specifications, ensuring consistency and quality
• Identified and reported discrepancies in materials and procedures, promoting continuous improvement and compliance
• Maintained accurate records in compliance with Good Document Practices (cGMPs) and SOPs
• Supported internal and regulatory inspections, ensuring consistent inspection readiness and full compliance at all times

• Enhanced product usability by identifying and resolving software issues, improving the user experience
• Delivered exceptional customer service, maintaining professionalism and addressing concerns in all client interactions
• Conducted thorough research to resolve customer complaints and inquiries, ensuring effective solutions
• Trained new employees on company systems and protocols, ensuring smooth onboarding
• Kept customers informed throughout issue resolution, providing clear and timely updates
• Maintained product knowledge to deliver informed, effective support and ensure customer satisfaction
• Provided expert assistance on hardware and software, using documented procedures and tools
• Analyzed customer issues and escalated when necessary, collaborating with teams to improve product performance
• Contributed to product improvements by identifying recurring issues and working with development teams
• Participated in product testing and communicated updates to minimize client disruptions
• Developed tailored solutions, leading to increased customer satisfaction, loyalty, and retention