Robert Hernandez, Mba (Honors), Clssbb, Cqia Email & Phone Number
Who is Robert Hernandez, Mba (Honors), Clssbb, Cqia? Overview
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Robert Hernandez, Mba (Honors), Clssbb, Cqia is listed as Senior Quality Assurance Specialist at Iovance Biotherapeutics, Inc., a company with 1009 employees, based in Sacramento, California, United States. AeroLeads shows a matched LinkedIn profile for Robert Hernandez, Mba (Honors), Clssbb, Cqia.
Robert Hernandez, Mba (Honors), Clssbb, Cqia previously worked as Manager, Quality Process Improvement at 4G Clinical and Senior Compliance Engineer at 4G Clinical. Robert Hernandez, Mba (Honors), Clssbb, Cqia holds Master Of Business Administration - Mba, Business Administration And Management, General from National University.
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About Robert Hernandez, Mba (Honors), Clssbb, Cqia
Innovative and results-driven Quality Manager with over 20 years of expertise in quality management and process improvement within the biopharmaceutical industry. Skilled in leading cross-functional teams to elevate Quality Management Systems (QMS), drive regulatory compliance, and enhance operational efficiency across global clinical trials. Known for implementing Lean Six Sigma methodologies to streamline processes, reduce deviations, and improve time to closure for CAPAs. Accomplished in inspection readiness, vendor qualification, and training program design to foster a culture of continuous improvement and regulatory excellence. Holds an MBA with Honors, is a certified Lean Six Sigma Black Belt, and a CQIA. Passionate about embedding a culture of innovation and continuous improvement that aligns with organizational goals and promotes exceptional quality standards.
Robert Hernandez, Mba (Honors), Clssbb, Cqia's current company
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Robert Hernandez, Mba (Honors), Clssbb, Cqia work experience
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Manager, Quality Process Improvement
Current- 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.
Senior Compliance Engineer
- 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.
Head Coach
- 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.
Assistant Softball Coach
- 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.
Compliance Specialist
- 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.
Senior Quality Assurance Specialist Ii
- 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.
Lead Biotechnician - Purification Operations
- 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.
Biotechnician
- 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.
Fabricator
- 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.
Diesel Mechanic
- 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.
Colleagues at Iovance Biotherapeutics, Inc.
Other employees you can reach at iovance.com. View company contacts for 1009 employees →
Raymond Li
Colleague at Iovance Biotherapeutics, Inc.
San Francisco Bay Area, United States
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MG
Michael Grosmick
Colleague at Iovance Biotherapeutics, Inc.
Franklinville, New Jersey, United States, United States
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CB
Carla Bass
Colleague at Iovance Biotherapeutics, Inc.
Sicklerville, New Jersey, United States, United States
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NK
Nasir Kemp
Colleague at Iovance Biotherapeutics, Inc.
United States, United States
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CH
Courtney Herman
Colleague at Iovance Biotherapeutics, Inc.
Tampa, Florida, United States, United States
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Z(
Zhihai (Harry) Qin
Colleague at Iovance Biotherapeutics, Inc.
San Francisco Bay Area, United States
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RZ
Rachael Ziskind
Colleague at Iovance Biotherapeutics, Inc.
United States, United States
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WH
Walter H.
Colleague at Iovance Biotherapeutics, Inc.
Harleysville, Pennsylvania, United States, United States
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JF
Jordan Furman
Colleague at Iovance Biotherapeutics, Inc.
Philadelphia, Pennsylvania, United States, United States
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JN
Justin N.
Colleague at Iovance Biotherapeutics, Inc.
Tampa, Florida, United States, United States
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Robert Hernandez, Mba (Honors), Clssbb, Cqia education
Master Of Business Administration - Mba, Business Administration And Management, General
Bachelor'S Degree, Organizational Leadership
Associate Of Science - As, Biotechnology
Frequently asked questions about Robert Hernandez, Mba (Honors), Clssbb, Cqia
Quick answers generated from the profile data available on this page.
What company does Robert Hernandez, Mba (Honors), Clssbb, Cqia work for?
Robert Hernandez, Mba (Honors), Clssbb, Cqia works for Iovance Biotherapeutics, Inc..
What is Robert Hernandez, Mba (Honors), Clssbb, Cqia's role at Iovance Biotherapeutics, Inc.?
Robert Hernandez, Mba (Honors), Clssbb, Cqia is listed as Senior Quality Assurance Specialist at Iovance Biotherapeutics, Inc..
Where is Robert Hernandez, Mba (Honors), Clssbb, Cqia based?
Robert Hernandez, Mba (Honors), Clssbb, Cqia is based in Sacramento, California, United States while working with Iovance Biotherapeutics, Inc..
What companies has Robert Hernandez, Mba (Honors), Clssbb, Cqia worked for?
Robert Hernandez, Mba (Honors), Clssbb, Cqia has worked for Iovance Biotherapeutics, Inc., 4G Clinical, San Juan Unified School District, Cepheid, and Genentech.
Who are Robert Hernandez, Mba (Honors), Clssbb, Cqia's colleagues at Iovance Biotherapeutics, Inc.?
Robert Hernandez, Mba (Honors), Clssbb, Cqia's colleagues at Iovance Biotherapeutics, Inc. include Raymond Li, Michael Grosmick, Carla Bass, Nasir Kemp, and Courtney Herman.
How can I contact Robert Hernandez, Mba (Honors), Clssbb, Cqia?
You can use AeroLeads to view verified contact signals for Robert Hernandez, Mba (Honors), Clssbb, Cqia at Iovance Biotherapeutics, Inc., including work email, phone, and LinkedIn data when available.
What schools did Robert Hernandez, Mba (Honors), Clssbb, Cqia attend?
Robert Hernandez, Mba (Honors), Clssbb, Cqia holds Master Of Business Administration - Mba, Business Administration And Management, General from National University.
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