Robert Hernandez, Mba (Honors), Clssbb, Cqia Email & Phone Number

Sacramento, Ca, Us

Remote

• Leading and overseeing the ongoing enhancement of the Quality Management System, internal processes, tools, and products.• Collaborating with quality and cross-functional teams to optimize processes.• Managing quality metrics and KPIs.• Fostering a quality-focused culture and improving employee onboarding and training.• Conducting audits and assessments to ensure adherence to quality standards.• Developing metric programs for analyzing supplier performance.• Participating in Client Audits as required.

Remote

• Ensured production studies were built, deployed, and supported in compliance with regulations.• Planned product releases to maintain compliance.• Investigated and resolved production issues.• Facilitated root cause analysis of study issues.• Authored, reviewed, and closed incident and CAPA reports.• Assisted with training content related to products and studies.• Led large-scale organizational change efforts.

Sacramento, California, United States

• Developed and implemented a training program that improved player skills in batting, pitching, fielding, and base running. Conducted regular practices for competitive play.• Planned and executed game strategies, making real-time decisions such as player substitutions and tactical adjustments.• Assessed each player's skills and potential, providing personalized coaching and feedback.• Conducted tryouts, selected the team roster, and determined player positions based on skills and team needs.• Ensured coaching practices were safe, monitored player health to prevent injuries, and managed any injuries that occurred.• Adhered to league, association, and school sports rules and regulations.• Served as a mentor, fostering personal growth and a positive team environment.• Maintained open communication with players, parents, coaches, school officials, and the community, handling team conflicts diplomatically.• Managed logistical aspects of the team, including scheduling games and practices, arranging transportation, and organizing events.• Ensured the team had necessary equipment and uniforms, maintained these items, and managed the allocated budget.• Attended games and scouted potential players for long-term team development.• Encouraged academic success among players, monitoring their performance to meet school and athletic standards.• Promoted the team in the community and engaged in community service to enhance visibility and support.• Oversaw fundraising efforts and managed the budget to ensure sufficient resources.

Sacramento, California, United States

• Assisted in planning and conducting practices to improve player skills and ensure safety during drills.• Worked directly with players on specific skills like pitching, batting, and fielding.• Helped with setup, player warm-ups, and in-game tasks such as strategy adjustments and player substitutions.• Aided in assessing players during tryouts and practices to advise the head coach on team composition.• Tracked players' development and health, communicated any issues to the head coach.• Managed team schedules, maintained attendance and performance records, and handled logistics for travel.• Ensured effective communication between players and coaching staff; acted as a mediator for disputes.• Guided players through sports and personal challenges, offering support and advice.• Represented the team at school and community events, participated in fundraising.• Stayed informed about coaching techniques and sport regulations through ongoing education.• Ensured all gear was maintained and ready for use.• Was prepared to manage emergencies and administer first aid if needed.

Lodi, California, United States

• Assisted in plant startup activities, including authoring and approving validation protocols and SOPs.• Provided technical support for deviation investigations and CAPA management.• Maintained and audited the quality management system.• Managed risk assessments and validation reports.

United States

Responsible for troubleshooting and guiding the resolution of Quality issues within the Roche/Genentech network through effective interdepartmental and cross-functional partnerships.• Drafted, reviewed, and approved SOPs, Change Records, Protocols, and Technical Reports; trained personnel on the Deviation Management System as needed.• Acted as the primary QA representative on a team overseeing compliance risks, investigations, and discrepant events.• Reviewed qualification campaign batch records, identified issues, and drove resolutions.• Provided expertise in interpreting policies, regulations, and guidelines to ensure compliance.• Communicated data on progress, opportunities, and next steps for key processes.• Provided technical assessments and approvals for cGMP changes.• Ensured quality oversight for the development and maintenance of compliance programs and procedures.• Participated as a subject matter expert in audits and inspections.• Authored discrepancy reports detailing actions, impacts, root causes, and CAPA.• Engaged in risk management and assessments.• Led continuous improvement initiatives to enhance group workload management.• Served as Genealogy Review Process Improvement Lead, reducing process review times from 12 days to 4 days.• Acted as the Vacaville Off-Shift Engagement Site Lead.• Lead and supported startup activities in Manufacturing, Fill and Finish, and Packaging plants.

United States

• Performed cGMP floor operation in buffer preparation, column chromatography, and tangential flow filtration (TFF) for ultra-filtration diafiltration (UFDF) final formulation, and bulk freeze of drug substances. • Provided input to shift supervisor on shift work assignments for other technicians.• Primary point of contact for QA and other departments.• Lead trainer for shift and department training team lead.• Implemented multiple process improvements to drive cost savings and continuous improvement.• Performed cycle counts as member of the Inventory Management Team in support of SAP implementation. • Participated in start-up activities for new Cell Culture Manufacturing facility. • Strict adherence to SOP in accordance to cGMP and cGLP regulations.

United States

• Performed cGMP floor operation in buffer preparation, column chromatography, and tangential flow filtration (TFF) for ultra-filtration diafiltration (UFDF) final formulation, and bulk freeze of drug substances.

Sacramento, California, United States

• Crafting, cutting, shaping, and assembling materials like steel, aluminum, and composites to create parts needed for transportation infrastructure projects such as bridges, road signs, and guardrails.• Performing different types of welding techniques (e.g., MIG, TIG, stick) to join or repair metal sections and components crucial to the structural integrity of transportation facilities.• Understanding and following detailed blueprints and engineering drawings to accurately produce required structures and components.• Maintenance and Repair Conducting routine maintenance and repairs on existing metal structures and equipment used in transportation projects to ensure their optimal functioning and safety.• Inspecting and testing fabricated components to ensure they meet quality standards and specifications set by Caltrans and safety regulations.• Operating various machinery and tools necessary for cutting, bending, and shaping metal and other materials.• Adhering to all workplace safety guidelines and practices, including the use of personal protective equipment and proper handling of machinery to prevent accidents.• Working closely with other team members, including engineers, project managers, and other fabricators, to ensure projects are completed accurately and on time.• Identifying issues in the fabrication process or with the materials used and coming up with effective solutions to keep the project on track.• Keeping accurate records of work performed, materials used, and any deviations from the original plans to ensure transparency and compliance with regulatory standards.

Roseville, California, United States

• Performing regular preventive maintenance on school buses and other diesel-powered vehicles, including oil changes, lubrications, and filter replacements to ensure they operate efficiently and safely.• Diagnosing and repairing problems in diesel engines, such as issues with the fuel injection system, exhaust system, and other critical engine components.• Troubleshooting and repairing electrical systems within the vehicles, including starters, alternators, and battery connections.• Inspecting and repairing brake systems to ensure they meet safety standards critical for transporting students.• Maintaining and fixing heating, ventilation, and air conditioning systems within the buses to provide a comfortable environment for passengers.• Conducting detailed safety inspections and compliance checks as per district, state, and federal regulations to ensure that all vehicles are safe for road use.• Maintaining accurate records of all maintenance and repair work conducted, including details of the services performed, parts replaced, and any incidents or irregularities noted during operations.• Responding to breakdowns and performing on-site or roadside repairs as needed to minimize downtime and disruptions in school transportation schedules.• Managing inventory of parts and supplies, ordering new parts, and ensuring that critical parts are in stock for routine maintenance and repairs.• Working closely with transportation coordinators, drivers, and other mechanics to ensure optimal operation of all vehicles and addressing any concerns related to vehicle performance or safety.• Staying updated with the latest diesel technology and possibly training other staff on new systems and equipment as they are introduced into the fleet.• Properly handling and disposing of hazardous materials like old engine oil and ensuring that the work environment complies with environmental safety standards.

Master Of Business Administration - Mba, Business Administration And Management, General

Bachelor'S Degree, Organizational Leadership

Associate Of Science - As, Biotechnology