Michael Guerrero

• Review and approve low-risk non-conforming events (NCE), deviation and CAPA.
• Review and approve pre-executed and manufacturing batch records for assigned clients.
• Prepare Manufacturing release checklist and COA's.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
• Interact with Manufacturing management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents, and reports findings to management.
• Interact with project team to assure that project requirements and details are understood and effectively translated into MFG records.
• Work with document reviewers to compile and review raw data, batch records and test results, including Final Reports and COA's, in accordance with cGMP, Code of Federal Regulations (CFR) and internal procedures in an efficient and timely manner. Assure that any observations /deviations are properly investigated and explained.
• Review SOPs.
• Review and approve document change requests.
• Coordinate execution of Manufacturing Suite Inspections.
• Thorough understanding of Good Manufacturing Practices.
• Contributes to the overall operations and to the achievement of departmental goals.
• Utilized SAP for raw material verification for manufacturing production.

• Maintained a safe work environment by strictly adhering to established safety protocols and guidelines.
• Ensure training qualifications and SOP's are up to date.
• Work as part of a team to perform production efficiently and complete batch records, forms, and documentation.
• Maintained compliance with regulatory standards and safety requirements.
• Perform material stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
• Identify errors and report them promptly to lab management. Participate in root cause analysis and implement corrective actions.
• Adheres to Good Manufacturing Practices(GMP) and Good Documentation Practices(GDP).
• Comply with safety SOP's, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
• Shadowed and observed environmental monitoring performing tasks in cleanroom.
• Environmental monitoring tasks included Passive air sampling, non-viable air sampling, surface sampling, and personnel plating.
• Gown trained and qualified.

• Perform routine experiments, tests, and procedures following guidelines that relate to Process Evaluation testing services.
• Prepare materials and buffers for projects.
• Make observations and accurately record data derived from cell plates via microscopy.
• Perform data analysis and final result reporting to support process release for clients.
• Adhere to protocols, SOPs, and cGMP/cGLP as they relate to specific tasks.
• Trained in cell based assays which include Cytotoxicity, Viral Interference, and TCID 50.
• Technical review of laboratory batch records for accuracy and adherence to cGMP SOPs.
• Collaborate with scientists to compose laboratory investigation of deviations and corrective/preventative action reports.
• Performed aseptic cleaning of safety cabinets before and after assay studies.
• Performed aseptic techniques used to prevent cross-contamination of cell lines and viruses.
• Ensured to wear proper PPE when entering positive and negative laboratories.
• Developed and maintained courteous and effective working relationships.
• Managed time efficiently in order to complete all tasks within deadlines.

• Developed a variety of cases involving murder, kidnap, and burglary.
• Each case involved the use of various forensic techniques for different types of evidence.
• Each case educates students on how crime scene investigators process a crime scene and document evidence.

- RESEARCH PROJECTS

• Suspected Suicide paper, December 2019.
• Researched different methodologies and means of suicides in a variety of case studies.
• Examined the impact of cases that included issues related to Entomology, Firearms, and Blood Stain.
• Pattern Analysis.
• Analyzed and produced a research paper that explained common ways that individuals commit suicide and investigate the background of the person.