Jessica Gutierrez, Asq Cqa Email & Phone Number

San Francisco Bay Area

California, United States

Libertyville, Illinois, United States

Libertyville

Lake Forest

Led Desktop Audits for Global Supplier Audit Program for API, Medical devices, Secondary containers, contract laboratories, distributor warehouses for excipients and primary components. Communicates effectively, verbally and in writing with diverse audiences and across various levels within organizations. Successfully led multiple projects and competing priorities. Anticipates obstacles and develops solutions within the team. Co-Authored supplier audits for API, Medical Devices, Secondary Containers, contract laboratories and excipients. Assessed compliance of systems, facilities and procedures per applicable regulations through audits and assessments of suppliers, assuring compliance to regulatory requirements.• Collaborated with SQM groups to improve the accuracy of ASL, Tier Levels and elimination of inactive suppliers.• Provided critical/marginal findings to management per GMP and GLP.• Completed CAPA closeouts to completion.

Lake Forest, Il

Led multiple bioassay testing laboratories, Subject Matter Expert for USP Antibiotic Potency. Evaluated technical and scientific data necessary for BQ testing to be in accordance with registration. Trained new analysts for USP and EP Antibiotic Potency testing, Heparin Sodium Bioassay and BET testing. Managed, wrote and approved laboratory investigations via Trackwise per GLP. Authored, reviewed and approved change requests via SAP DMS.• Established effective working relationships with multiple functional groups, i.e., Compendial Affairs, R&D Micro, Metrology and Documentation, in order to fulfill commitments.• Site Champion for Lab Optimization, coordinated with Managers in BQ and CQ to maintain structure for lab efficiency in BQ and CQ laboratories, presented findings to VP’s, Directors and Managers.

Lake Forest, Il

Provided method development and validation of transferred products from Australia, ensuring compliance with the European Pharmacopeia. Supported the improvements of biochemical assay method, Antibiotic potency, for Vancomycin, Subject Matter Expert.• Performed assays and verified test results for the release of JP Propofol final product.• Evaluated raw materials, final product and product stability for endotoxin using gel clot.

North Chicago, Il

Conducted BET validation protocols run by Engineering. Trained individuals tin the use of PQ and EM LIMS and Citrix Metaframe. Executed calibration of Total Organic Carbon (TOC) Analyzers, testing of water for TOC, conductivity , heavy metal and nitrate testing. Performed aseptic testing of WFi, PurW and Autoclave cooling water used in the LVP and SVP manufacturing process as well as in the support of validation protocols.• Conducted aseptic monitoring of hospital products in Class 5/EYU Grade A and B areas including surface monitoring (rodac and swab), basic staining, personnel monitoring and air sampling.