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Lorena Guzman is listed as Pharmaceutical Manufacturing Compliance, Senior Specialist based in San Francisco Bay Area, United States, United States. AeroLeads shows a matched LinkedIn profile for Lorena Guzman.
Lorena Guzman previously worked as Senior Specialist Pharmaceutical Manufacturing Compliance at Boehringer Ingelheim and Manufacturing Technician at Boehringer Ingelheim, Formerly Amgen Inc.,.
Results-oriented contributor with 15+ years experience in the pharmaceutical industry, including Manufacturing Quality Compliance, and drug product FillingExperienced in Quality Systems: Deviation investigator, CAPA owner, Change Control, and technical writing (SOPs)
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Fremont, California, United States
Lead cross-functional teams in deviation investigations and implementation of Corrective and Preventative Actions. Developed change control plan and managed execution of new product introduction, process performance qualification (PPQ) and process change controls. Lead team audit preparedness efforts and provided support in regulatory/internal audits.
Ensured manufacturing area was free of cross-contamination by performing area/equipment changeover for new product introduction
Supported quality control by performing environmental monitoring of the manufacturing facility
Ensured manufacturing aseptic filling equipment and materials met cGMP standards by granting line clearance. Supported commercial drug batch release by reviewing and releasing batch records.
Supported device development by testing pulmonary delivery systems and preparing data summaries for regulatory submissions
Researched plant genomics by performing biochemical assays and microscopy on transgenic plants
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Lorena Guzman is listed as Pharmaceutical Manufacturing Compliance, Senior Specialist.
Lorena Guzman is based in San Francisco Bay Area, United States, United States.
Lorena Guzman has worked for Boehringer Ingelheim, Boehringer Ingelheim, Formerly Amgen Inc.,, Genentech Inc, Nektar Therapeutics, and Mendel Biotechnology.
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