- Assisted complaint team in developing investigation portion of complaints, inputting and developing complaints within Excellence Through Quality (ETQ) system- Assisted in development of Standard Operating Procedures and Work Procedures for returns and complaint investigation activities

- Doc Control, Regulatory Support, Quality Management Systems, Quality Assurance, GMP, Technical Report Writing - Aseptic Environment, Audit prep, and Lab Compliance within Biotech Industry. FDA QSR 820.50 and ISO13485

Regulatory Specialist, Gilead Sciences, Inc., La Verne, CAContracted through Aerotek, Santa Ana, CAJune 2016 – March 2018- Conducted GxP training for new fill line operations (material transfer, autoclaving, area cleaning, aseptic filling) in ISO Class class 5 through class 8 pharmaceutical manufacturing- Prepared procedural, training, and other support documentation for facility launch- Supported validation teams and prepared documentation for manufacturing area (equipment and processes) within various cleanroom environments

Validation Specialist, Life Science Outsourcing, Brea, CASeptember 2015 – June 2016- Prepared and executed protocols and final reports for ethylene oxide and steam sterilizations for hospitals, medical device companies, and pharmaceutical companies- Operated Ethylene Oxide and steam sterilization equipment- Prepared all related documentation for sterilization validations and production orders- Executed all pertinent microbiological inoculation and sampling as part of final reporting

Updated PMS section of company CE files to bring into compliance with European and other international standards- Analyzed CE files and performed requisite risk analysis procedures

- Assisted in most phases and in multiple levels of the company QMS- Performed as primary reviewer and authorization agent for company batch records- Assisted with regulatory submissions to FDA, CMDR, and EU regulatory structures- Updated supply chain documentation to comply with ISO 13485 and FDA 21 CFR 820 per ISO 13485 audit, resulting in the removal of previous audit observation- Updated validation/qualification protocols regarding facility equipment per auditorrequest- Conducted audit of sister company, resulting in the correction of previous observations- Performed incoming and outgoing product quality inspections, contributing to a 12.7%increase in the rate of company shipments over a two year span

- Assisted with DHR inspections for RA/QA, Purchasing, and Receiving departments.- Reorganized and populated company DMRs for Biolis, Olympus, and Synchron reagent systems to comply with ISO and FDA formats.- Learned and applied FDA and ISO regulations for compliant DHR and DMR files.- Filed and packaged accumulation of DHRs for off-site storage.- Conducted QC and maintenance activities inside of in vitro diagnostic lab. - Assisted with synthesis of chemical reagents for IVD applications.