Cesar S. Email & Phone Number

Gardena, Ca, Us

Garden Grove, California, United States

Gardena, Ca

• Provides coordination of quality procedures, instructions, specifications, and standards to ensure compliance with applicable law, Local, State, and Federal (i.e. FDA), ISO, EHS and customer specifications/requirements worldwide.• Leads, trained and implements QMS, cGMPs and Environmental, Health and Safety Plan (including COVID-19 Prevention Plan).• Reviewed, revised and developed standard operating procedures for ISO 13485, 21 CFR 820, cGMP and other documentation protocols and forms.• Perform and oversee IQ/OQ/PQ validations, creates summary & final reports validation, validation protocols, process mapping, etc.• Oversee and maintain quality planning, non-conforming material, out-of-specification, deviation, in-house and 3rd party testing & documentation, document and data control, and corrective action system or CAPA; including Environmental, Health and Safety. • Facilitate teams for root cause analysis and corrective action determinations and implementation.• Specifies and maintains necessary QC equipment to ensure conformance to customer specifications.• Oversees and performs (external and internal) auditing functions (including regulatory audits).• Regularly analyses services provided for the customer to develop new ways to better satisfy customer needs (new/different equipment, alternative work methods, improved quality/ service, etc.)• Supports the improvement of shop floor workflow and Quality Process: specification, justification, and acquisition of new equipment rework/improvement of existing equipment.• Provides periodic quality summary reports for Management Review (incl. Safety Reports).• Educates/trains/coaches all employees on GMP, quality, continuous improvement and EHS/Safety practices.• Design, organize and complete the employee training programs (for cGMP/ISO/FDA and Safety).• Oversees technical writing projects concerning quality, production and safety practices.• Completes other tasks and projects as assigned by the President.

Torrance, Ca

• Writing new and revising current standard operating procedures (SOPs), specifications, forms, summary reports, IQ/OQ/PQ validation protocols, process mapping, etc.• Oversee IQ/OQ/PQ validations, deviations, CAPA and product complaints• Perform GMP compliance improvements and GMP audits for all internal operations.• Reviewing all GMP documentation, including Batch Production Records (BPRs) and monitoring data• Recommends and implements new policies and procedures to improve existing process and products.• Reviewing trending data and provide support to customer and regulatory audits• Other duties as assigned by the Quality Engineering/QA Manager.

El Segundo, Ca

• Leads, plans, directs, and coordinates daily activities of the Quality Assurance Department.• Ensures raw materials, bulk, components, in-process and finished goods meet requirements and specifications.• Managed and monitor QC/QA staff in all activities in laboratory, incoming, in-process, and finished goods.• Ensures all state and federal regulatory requirements for facility registration are addressed prior to manufacturing new products. manage product safety• Developed, trained, and lead QC/QA, and operations personnel on Company standards and policy, including, SOP(s)and safety programs.• Prepare standard operating procedures and other documentation protocols and forms• Set up and maintains documentation controls and procedures• Liaise and advise managers and other staff on the implementation and performance of the quality management system and coordinate quality assurance issues with management• Determine training requirements and train employees on all applicable standard operating procedures• Conduct vendor and internal audits• Prepare Safety Data Sheets (SDS) of newly manufactured products• Manage Master Files, retain samples (raw, bulk and finished goods) and Outside Laboratory documentation, as well as review batch records, QA/QC documentation, etc.• Responsible for the over-all operations of the Regulatory and quality assurance aspects of the company, and serve as the primary FDA contact, including submission of documents, labels and ingredients listings to FDA. • Streamlined production and quality documents, eliminated bottlenecks on paper related inefficiencies by reducing duplicates or redundancy items, created a system to find critical documents/records when they are needed and a logical location that is easily found and retrievable.• Currently establishing an effective Product Safety Management Program and Validation Program.• Other duties as assigned by the CEO of California Vapor/Cosmetix West

Santa Fe Springs, Ca

• Assess and review FDA 483 Observations and Notice of Violations• Performed Regulatory GAP analysis and ensure all applicable regulations are met.• Authored, revised Standard Operating Procedures (SOPs), Inspection Methods, Work Instructions and Improved all Quality Systems aspects for compliance to 21 CFR Part 11, 210 and Part 211.• Plan, prepare, conduct and report process and systems audits (1st, 2nd, 3rd party audits), validations (IQ, OQ, PQ plus Cleaning and Sanitization), and other audit activities.• Completed vendor qualification audits, assessments and questionnaires based on vendor risk.• Review IT validation deliverables for GxP compliance; including system and risk assessment, 21 CFR Part 11 Assessments, Calibration Plans and Reports, Test Plans and reports, and Change Control Documentation.• Performed compliance, qualification and verifications audits including validations of equipment, procedures, test methods, as well as software utilization such as HPLC, UV/VIS Spectrometer, FTIR, pH Meters, etc.• Worked with VP of Technology and Regulatory to determine suitability of labeling and other practices and submit SPL (Structured Product Labeling) to FDA via FDA Gateway.• Monitored current practices, processes and trained department managers, supervisors and all personnel for internal and external policies, industry standards and applicable regulations.• Helped and effectively resolve several FDA 483 Observation – Notice of Violation, by establishing and enhancing cGMP compliance and implementing effective prevention based Quality Systems.• Other duties as assigned by the VP of Technology and Regulatory Affairs.

Gardena, Ca

• Responsible to the OVERALL general affairs, compliance and operations of the organization, equipment/facilities, safety/security, manufacturing standards, protocols, etc.• Ensured that there are no breakdowns in the manufacturing operations thru regular inspections and maintenance of equipment, etc.• Managed and ensure compliance to FDA, cGMP, NOP, including OSHA, EPA, USDA, and responsible for all licenses, permits, insurances, certificates, agreements, etc.• Established and authors procedures, work instructions, protocols for Validation (IQ/OQ/PQ), Stability Testing, Audits, etc.• Coordination and preparation of all FDA & USDA-NOP Regulatory submissions (i.e. organic submissions), and serve as the Primary point of contact.• Hosted FDA & State of CA Inspections, ISO and Customer Audits.• Creating and maintaining product technical files, master & batch files, raw material and finished product specifications, document control, safety docs., etc. • Approved/Released/Maintained OTC and Organic NOP documents and reconciliation paperwork.• Lead in acquiring OTC/Drug Manufacturing Certification, Organic NOP Certification.• Observed & implemented EHS regulations, encouraged safe working practices, and safety programs (incl. Emergency Response preparedness, etc.)• Orchestrated the mindset of all personnel to give the best quality everyday.• Managed calibration and preventive maintenance programs, cleaning & sanitization programs and environmental health & safety programs.• Responsible for handling non-conformances (CAPA), out-of-specification investigations, complaints, internal and external audits, root cause & risk analysis, etc.• Responsible for identification and reviewing labels for compliance.• Trained Production Staff/Supervisors, Engineers, and Back Office, etc. on bi-monthly on Processes, standards and procedural training (SOPs, GMPs, EHS Policies/Programs etc.) • Attended Dietary Supplement Training by NSF.• Other duties as assigned by the CEO.

Gardena, Ca

• Ensured that there are no breakdowns in the manufacturing operations thru efficient planning and scheduling, regular inspections and maintenance of equipment, and leading the best team of subordinates.• Maintained current knowledge of FDA and international regulation, guidance and standards applicable to all products, as well as performing compliance research and tracking methods for quality process improvements.• Responsible for all Local, State and Federal, Quality, Regulatory, Safety and the whole Plant• Established and authors procedures, programs, methodologies, work instructions, guidelines and developed protocols for Validation, Stability Testing, Installation, Operations and Performance Qualification.• Coordination and preparation of all FDA & USDA-NOP Regulatory submissions (i.e. Product listing, license, registration & establishment renewals and organic submissions), and serve as the Primary FDA point of contact.• Creating and maintaining product technical files, master & batch files, raw material and finished product specifications, document control, safety docs., etc.• Observed & implemented EHS regulations, encouraged safe working practices, maintained incident/accident logs, trainings and safety programs.• Managed equipment calibration and preventive maintenance programs, cleaning & sanitization programs and safety programs throughout the entire company.• Responsible for handling non-conformances, complaints, internal and external audits, RMA & MRB.• Trained Production Staff/Supervisors, Engineers, and Back Office, etc. on Processes, standards and procedural training.• Performed root cause & risk analysis and investigation of significant production process and quality issues. Also includes corrective and preventive actions CAPA.• Developed Food Safety, Hygiene & Sanitization, Regulatory and Dietary Supplement compliance programs• Attended Dietary Supplement Training.• Other duties as assigned by the CEO.

Torrance, California

• Developed and implemented tests suites, and performs process, equipment and software validations for X-Ray Full Body and Baggage Scanner Systems, Gamma-Ray Inspection Systems, etc.)• Developed, maintained and initiated standards and methods for inspection & testing (i.e. computer systems, x-ray generator, circuit boards, incoming parts/cables and other assemblies)• Conducted internal and external audits, corrective/preventive actions (CAPA), complaints, root cause, returns and conduct source inspections (FAT & SAT) in a timely fashion.• Ensured and maintained calibration program, and authored SOPs and Work Instructions, Checklist, etc. and trained team members on ISO 9001 and Quality procedures & guidelines.• Generated annual, quarterly and monthly reports and reviewed all internal processes to eliminate waste.• As a QA technician (from Sept 2003-April 2004) – responsible to all incoming machine/mechanical parts, cables, wires, metals and assemblies, electronics boards and computers parts etc. and ensure that they are thoroughly inspected and verified upon strict compliance with ISO Standards.• Performed First Article for new parts, new vendor and/or suppliers and accountable for all inventory on all rejected, faulty/failed parts; and performed in the disposition of non-conforming material (MRB & RMA).• Assist the Director of Quality in preparing documents on ISO audits and inspections.• Attended lean manufacturing training and with working knowledge of six-sigma, kaizens etc.• Carried out special projects assigned by the Director of Quality and other duties as time necessitate.

Torrance, California

• Develops plans to evaluate process repeatability and stability; • Participates in procedure writing and review and Performs process & equipment validations• Oversees that all incoming parts, cables, wires, metals and assemblies etc. are thoroughly inspected and verified upon strict compliance with ISO Standards.• Performs First Article for new parts, new vendor and/or suppliers and accountable for all inventory on all rejected, faulty/failed parts; and performed in the disposition of non-conforming material.• A member of the Material Review Board (MRB) for the disposition of non-conforming material and generate reports on Return Material Authorization (RMA).• Conducts Final and In-process source inspections in a timely fashion.• Other duties assigned by the Director of Quality.

Los Angeles, California

Maintaining and repairing equipment on-site/off-site, setting-up and installing new equipments on customer's network, i.e. include software installations/upgrades Providing outstanding support by meeting customers' needs in a courteous and timely manner.Encouraging the purchase of maintenance contracts and accessories Diagnosing and resolving maintenance and repair issues Managing and maintaining accurate inventory for tools, parts and supplies Providing accurate billing and collection for services renderedResponsible for submitting legible paperwork in a timely manner