Experience

Expression Systems

• United States
• Biotechnology Research
• 1 - 100 Employee

• Quality Assurance Specialist III

  • Jan 2022 - Present

  Davis, California, United States



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• QA Specialist-Data analyst

  • Nov 2013 - 2016

  Vacaville CA Perform QA review and approval of raw materials according to GMP procedures and pharmaceutical industry regulations to determine disposition of lots requiring minimal supervision to meet assigned targets and timelines. • Raw Material Batch Approval: Approved/released of raw material batches based on global GMP guidelines and regulations. QC Data review, pharmaceutical industry and regulated testing procedures, identification, initiation and resolution of discrepancy and deviations and CAPA.… Show more Perform QA review and approval of raw materials according to GMP procedures and pharmaceutical industry regulations to determine disposition of lots requiring minimal supervision to meet assigned targets and timelines. • Raw Material Batch Approval: Approved/released of raw material batches based on global GMP guidelines and regulations. QC Data review, pharmaceutical industry and regulated testing procedures, identification, initiation and resolution of discrepancy and deviations and CAPA. Internal and external audits collaboration. • QA Genealogy Review: Reviewed manufacturing functions of Single Process Orders (SPO’s) for all products and use quality databases such as ERP (SAP), POMS QA, OLRT and TrackWise to identify operations issues. Managed large amounts of database. Applied safety and legal procedures. • Approval and Disposition Communication: Reported business and GMP issues to multi-site management according to FDA, PQS and company policies and procedures. Provided training and support, Identify areas of improvement. Show less