Traci Mercer-Hall

• Conduct investigations and identify RCA of deviations for solid dose, vaccine manufacturing and packaging, medical devices and suppliers/ vendors
• Investigation of environmental excursions, consumer complaints & manufacturing deviations within oral solid dose, vaccine and MDI packaging areas
• Determine RCA and identify robust and effective CAPAs in manufacturing and packaging deviations
• Audit regulatory documents for completeness, accuracy and compliance for release of marketed products
• Review and approve SOPs outlined for areas of Quality, Packaging and Engineering
• Partner with external suppliers with investigations and identify root cause & capas.

• Quality oversight leader of Operations. Approve validation protocols and batch documentation for accuracy, completeness, and conformance to cGMP
• Managed a team of 18 QA staff, ensuring quality inspections and compliance of raw materials and finished goods
• Review analytical data and manufacturing batch records for final disposition of raw materials and finished goods
• Author, review and/or approve deviations, CAPAs and consumer complaints investigations

• Reviewed global regulatory observations and collaborate with SMEs to determine impact to GSK supply sites
• Coordinated SME's for interpretation of internal audit findings, regulatory inspections, pharmacopeia information and ICH 7 guidelines and initiatives
• Challenged technical support and production groups to ensure robust root cause analysis and identification of corrective actions

Quality Leader for 3rd party marketed products

• Audited manufacturing & packaging batch documentation for 3rd party sites across N.A & Europe; ensuring accuracy, completeness and compliance to regulatory requirements
• Managed change control documentation with sister GSK sites and contract manufacturers
• Managed Quality Agreements, for contract vendors/suppliers
• Conduct risk assessment and implement corrective actions for 3rd party suppliers/contractors.

• Managed a staff of 13 scientists to ensure the analytical testing and release of marketed sterile dose products
• Audited manufacturing batch records for completeness, accuracy, and compliance
• Led weekly meeting with senior management for deviation trending and compliance issues
• Authored Annual Product Reports and consumer complaint trending for LVP and FCF products