Wendy Islas Email & Phone Number

Taylorsville, Utah, United States

GLP Studies* Review each GLP study prior to release for testing.* Audit a portion of each GLP study to ensure compliance with regulations, standards, and procedures.* Review each GLP study and final report prior to mailing.Regulatory and Policy & Procedural Guidance* Know and follow GLP, GMP and relevant ISO regulations* Review standard procedure documents in Master Control (collaboration and approval)Process Improvement* Meet regularly with Section Leader, Study Directors and Lab Analysts* Audit and review in-process testing and data* Assist QA Regulatory with internal audits* Review validation protocols, raw data, and reports

• Performed GLP and Non-GLP testing inside of a Cleanroom, maintaining almost zero contamination events.• Coordinated between Isolator, Bacteriostasis/Fungistasis and ISO Class 6 Cleanroom to increase turnaround time.• Maintained less than 1 quality event per quarter.• Restructured Bacteriostasis/Fungistasis training procedures along with department scientist to decrease errors among testing and achieve consistent results.• Hands-on Trainer, training from Aug 2021 forward employees working within Cleanroom.• Crossed trained in other areas of the lab including Bioburden testing and Bacterial Endotoxin testing.• Trained in data review ensuring compliance with standards and procedures.