QA review, editing, approvals of site facility and equipment installation and operation qualification protocols for GMP release.Key contributor to assist in finalizing AOP for QA providing a structured roadmap for the department's costs/activities throughout the year.Defined requirements for phase-appropriate systems laying the groundwork for efficient and scalable processes.Review and approval of Inceptor Bio QAA (Quality Assurance Agreement) establishing foundation for collaboration and quality standards.Successfully established Quality Assurance Agreements with key external vendors—WUXI, Biomeriux, Bionique, and Gateway.Continuous key QA stakeholder for all site procedural documentation and implementation activities to drive towards GMP readiness.EDMS and ETMS systems owner ensuring compliance and accountability in the processing of procedural documentation and site training efficiencies.Implementation of paper-based systems for document control and training while developing the implementation plan for remaining Quality Management Systems.Established the vendor qualification program including procedure, assessment documentation and approved vendor list.Validation and implementation of the Veeva EDMS and ETMS systems.Quality oversight for implementation of applicable procedures for quality control to support laboratory startup.Creation and implementation of the Change Control process/procedure.Continuous review and approvals for operational procedures, qualification protocols and operational processes of site systems including the implementation of CSV Phase II, Dynamics, Blue Mountain.Supported QC in establishing the elements required for a phase appropriate raw material specification program.

QA review, editing, approvals of site facility and equipment installation and operation qualification protocols for GMP release.Key contributor to assist in finalizing AOP for QA providing a structured roadmap for the department's costs/activities throughout the year.Defined requirements for phase-appropriate systems laying the groundwork for efficient and scalable processes.Review and approval of Inceptor Bio QAA (Quality Assurance Agreement) establishing foundation for collaboration and quality standards.Successfully established Quality Assurance Agreements with key external vendors—WUXI, Biomeriux, Bionique, and Gateway.Continuous key QA stakeholder for all site procedural documentation and implementation activities to drive towards GMP readiness.EDMS and ETMS systems owner ensuring compliance and accountability in the processing of procedural documentation and site training efficiencies.Implementation of paper-based systems for document control and training while developing the implementation plan for remaining Quality Management Systems.Established the vendor qualification program including procedure, assessment documentation and approved vendor list.Validation and implementation of the Veeva EDMS and ETMS systems.Quality oversight for implementation of applicable procedures for quality control to support laboratory startup.Creation and implementation of the Change Control process/procedure.Continuous review and approvals for operational procedures, qualification protocols and operational processes of site systems including the implementation of CSV Phase II, Dynamics, Blue Mountain.Supported QC in establishing the elements required for a phase appropriate raw material specification program.

Managed and assisted in the implementation and maintenance of electronic QMS systems, Document Management, and Training.Provide or support training of all GMP functional areas.Coordinated and supported the creation of and revisions to Standard Operating Procedures (SOPs).Supported Arranta Bio customers to ensure satisfaction and compliance for their clinical and commercial programs.Managed QA Systems staff and processes driving innovation, teamwork and efficiency within the organization.

Managed and assisted in the implementation and maintenance of electronic QMS systems, Document Management, and Training.Provide or support training of all GMP functional areas.Coordinated and supported the creation of and revisions to Standard Operating Procedures (SOPs).Supported Arranta Bio customers to ensure satisfaction and compliance for their clinical and commercial programs.Managed QA Systems staff and processes driving innovation, teamwork and efficiency within the organization.

Responsible for the quality compliance of facility deviation and CAPA systems.Stakeholder in the implementation of a new TrackWise quality management system.Direct contact with external and internal customers with respect to quality systems, quality process improvements, quality audits/complaints, and regulatory compliance.Implemented good documentation practices at the site introducing proper correction procedures for all controlled documentation.Key quality reviewer of root cause analysis outcome identifying and initiating appropriate corrective and preventive actions (CAPAs)Cross-training as a Quality Manger for new quality personnel involved in multiple quality systems.Owner of process improvements associated with investigation processes to streamline deviation process driving reduction in cycle time by 20%.

Quality representative including deviation investigations, root cause analysis, corrective and preventive actions and site-wide process improvements.Provided Quality expertise and leadership in support of all activities related to deviations and CAPAs.Created and led QRM weekly meetings ensuring proper deviation classification based on risk analysis including CAPA evaluation/implementation.Developed and maintained QMS metrics to ensure continuous improvement through RCA and CAPA evaluations.

Developed site project plan responsible for the successful completion of plant closure GMP activities for 3 manufacturing buildings initiating and executing 150+ change controls and 1000+ GMP pieces of equipment, facilities, utilities, computer systems and instruments in 6 months.Successful collaboration with Quality to update working forms providing a better streamlined process and reducing downtime during change over by 30% and reducing human error related deviations by 50%.Implemented a strategic packaging schedule working with production planning to meet market demand while reducing downtime and hourly overtime costs.Instrumental in vacating site Consent Decree with final FDA audit prior to site closure.Subject matter expert responsible for interaction with federal regulatory agencies including the FDA and third-party auditors.Formulated and maintained efficient daily, weekly and monthly metrics reports trending cycle times, performance to master schedule, and cost transactions including recommendations for improvement supplying accurate and complete information to support compliance and current business strategy.Instituted 5S and lean operations in packaging by recognizing and recommending opportunities in production improvement in cycle times, headcount, and excess inventory to drive down cost and resources.• cGMP Compliance• Root Cause Analysis• Technical Writing• Project Management• Investigations• FDA and DEA Audit Experience• Leadership and Team Building• Training and Coaching• Process Improvement• Manufacturing Compliance Support• Packaging Compliance Support

Team leader in site-wide deviation reduction project writing, reviewing and implementing process improvements to close out over 250 open deviations in less than three months.Published and implemented site wide gowning procedure and practice changes focusing on reducing deviations related to foreign material.Represented the Quality department for manufacturing operations in maintaining minimal open deviations by reducing required standard closure times by 30%. Experienced in cGMP compliance with technical expertise in manufacturing as well as Quality Assurance.Strong technical writing skills using current elements in risk analysis.Subject Matter Expert for cGMP FDA inspections and providing investigations and updates to FDA on Field Alerts and recommended Market Actions.Demonstrated success in writing, reviewing, and approving Procedures, Protocols/Reports and Change Controls.• Quality Assurance• cGMP Compliance• Root Cause Analysis• Technical Writing• Investigations• FDA and DEA Audit Experience• Leadership and Team Building• Manufacturing Compliance Support• Packaging Compliance Support

Led a cross functional department overseeing all laboratory purchasing, receiving, storage and inventory control of schedule CI-CIV controlled substances, laboratory samples, testing standards, analytical impurities, equipment, and instruments.Instituted successful system for outsourcing the ordering and inventory of all laboratory consumable goods by bringing in 3rd party vendor on site as a cost reduction initiative.Represented laboratory operations as subject matter expert relating to FDA and DEA inspections regarding the inventory, receipt, storage and destruction of analytical samples including controlled (CI-CIV) substances.Supervised, trained, mentored, and provided leadership and direction to employees and 3rd party contractors on site.• Quality Control• cGMP Compliance• Root Cause Analysis• Technical Writing• Project Management• Investigations• FDA and DEA Audit Experience• Leadership and Team Building• Training and Coaching• Process Improvement

Veteran; Honorable Discharge