• Manage all aspects of IT infrastructure and application implementation related projects• Lead project teams and/or work-streams• Utilize sound project management and SDLC methodologies• Ability to work in a matrix managed environment where many resources are embedded part time on a particular team• Develop and manage project intake process and resource capacity planning• Escalate issues early and provide concise issue descriptions to upper level management coupled with recommended paths for resolution• Executive presence and good presentation skills• Liaison between internal customer, IT and external contracted resources and/or firms• Vendor management including selection and vendor contracting/negotiation

• Mentor manufacturing compliance staff• Drive improvement of the technical capabilities and quality practices within thedepartment• Coordinate activities and resolve issues across the department, other groups, and/orprojects• Respond to and/or resolve recurring technical or processing issues• Develop and implement novel approaches to solving non-routine technical problems• Own metrics related to manufacturing compliance• Lead improvements in processes and methods that reinforce cGMP within thedepartment and/or across the site• Participate directly in internal, external, and global health authority audits/inspections• Apply systematic thinking processes and technical knowledge to independently addressa broad range of non-routine to moderately complex problems• Conduct investigations, demonstrate strong technical and problem-solving skills, andexcellent technical writing skills• Provide training and guidance on the staff to meet the goals of the department• Provide routine updates on progress, status, and issues associated withcampaigns/projects• Provide support and/or direction to junior staff when necessary• Exercise sound judgment when making decisions• Make critical decisions in collaboration with key stakeholders• Demonstrate accountability for personal, departmental, and organizational initiatives

• Interface with internal and external auditors to coordinate site inspections• Act as Backroom Manager during Client and Regulatory Inspections• Enter observations of inspection into the site Quality System • Confirm assignments/due date and promotes communication to ensure timely response of audit observation. Schedule and lead forums to ensure progress of audit response• Finalize responses into the site Quality System, coordinate signatures on response, and send to Client as applicable• Confirm CAPA is opened into the site Quality System open and tied to audit finding• Drive reporting on progress of commitments and provide updates/ escalations to site leadership• Support management to drive a quality culture by executing an inspectional preparation strategyaligned to business goals to achieve positive results for the organization• Support alignment of local inspection program with global Policy requirements

During this time I will design and provide program structures for implementation cross functional departments, to ensure and support compliance adherence.

• Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, and Validation team• Provide support to manufacturing staff for new equipment and processes.• Ensure process optimization and continuous improvement.• Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.• Collaborate with engineering and validation teams to implement and qualify new equipment and controls.• Author and update quality documents, such as Standard Operating Procedures (SOPS) and other technical procedures.• Follow-up on production campaigns including client communication, review and approval of batch records, troubleshooting, handling of deviations and CAPAs.• Participate in customer meetings providing manufacturing updates.• Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression• Work closely with Manufacturing operations and QA team to drive CAPAs to timely closure• Provide support in quality system programs such as Deviation, CAPA, Change Management• Serve as liaison between multiple groups including Manufacturing, Quality, and Process Development

» Spearheaded relevant project teams through organizing meetings, schedule coordination, work statements management, budget control, SOP generation, as well as administering updates and changes to scope and work statements» Meticulously organized quality control documents and technical reports using various word processing and analysis programs» Devised new and improved SOP for order processing escalation to executive management regarding product intake inspection failure» Solely responsible for the oversight and management of receiving/intake functions, cycle counting, and inventory accuracy & reconciliation» Optimized manufacturing methods by over 30% throughout the SEED facilities by documenting process flows, production schedules, production rates/efficiencies, and making recommendations for improvement» Expertly supervised a staff of 16 production personnel while ensuring safety, training, and quality compliance were prioritized to meet manufacturing goals» Ensured the implementation of Federal, state, and local quality assurance and control regulations into all processes and procedures» Oversaw consistent production of all amniotic membrane, medical devices and production lines to operate within established quality guidelines and ensured appropriate actions and communication for any deviations» Regularly performed audits to ensure that lab environments met & exceeded all necessary clean room regulation standards, ensuring a 100% uptime for lab facilities» Efficiently trained existing and new staff in manufacturing functions and improved processes in training/onboarding workflows» Managed all relations with distributors to ensure accurate account information, order processing accuracy, and information security

» Generated and controlled all quality system and manufacturing documentation including bill of materials and related documents» Project leader for design control regarding medical device development, with additional contributions as the quality reviewerfor the team and resource for assurance of standards compliance throughout implementation» Sustained and inspected equipment to ensure safety, reliability, and efficiency of operation» Identified areas of opportunity for all stages of the manufacturing process and created actionable documentation to escalateopportunities concisely to management» Liaised with suppliers/vendors, implemented test procedures, formulated and demonstrated processes to clients/managers» Generated adequate reports and documentation, provided technical advice, and consistently analyzed and interpreted data

• Responsible for orders of supplies or request for services, and ensuring receipt prior to date of need. • Responsible for reporting and communicating on a daily basis with Facility Personnel to facilitate activities aligning with QAD and QAS direction and objectives.• Ensures that all executive management team and QAD are aware of all critical issues.• Responsible for receiving/preparing purchase orders, invoices, and/or pack slips for the distributors.• Responsible for managing controlled inventory and records.• May review donor file record contents.• Responsible for ensuring monthly quality documentation is generated, completed, and filed.• Responsible for assistance with the preparation of Marketing Collateral, and management and maintenance of published article archives.• Responsible for reconciliation of inventory on a continuous basis.• Serves as the point of contact for all technical question that may come from customers• Assist with the preparation of the annual audit report for management review.• Monitors all quality records to ensure compliance.• May conduct audits or perform quality technician duties.• Maintains confidentiality of all patient information according to federal and state guidelines and regulations.• Performs other duties as assigned.• Will be cross trained on all critical production flow jobs and could fulfill facility technician or quality technician duties.

• Prepares Quality Procedures.• Reviews form entries and verifies completion of all paperwork.• Inspects products, complete forms, and quality records for compliance with Seed Biotech, Inc. requirements.• Assists with tracking, tracing and inventory management of tissue for transplantation from receipt to post distribution.• Conducts audits as requested.• Prepares reports as requested• Assists with Doc Control and Management of personnel, equipment/instrument, donor files, shipping/receiving & Inspection Logs, etc. and all Quality Records.• Performs quality checks of finished products and labeled units.• Performs monitoring assessments of controlled environment parameters.

• Authored Quality Assurance specifications and production documents for animal tissue material based medical devices.• Conducted Internal audits of facility systems and ensured compliance with all in-house and mandated regulation.