Experience

Mariposa County

• United States
• Government Administration
• 1 - 100 Employee

• Certified Appraiser

  • Feb 2022 - Present



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Compliance Specialist II

  • Jun 2021 - Nov 2021



Dr. Bronner's

• United States
• Manufacturing
• 100 - 200 Employee

• Bulk Operations

  • Mar 2020 - May 2021

  Creates and revises SOPs, Work Instructions, and Batch Records for new in-house processes. Works with team to increase efficiencies, safety, and communication. Performs daily operations activities including refining oil, manufacturing bar soap, boiler operations, stocking supplies, and equipment troubleshooting and maintenance. Creates and revises SOPs, Work Instructions, and Batch Records for new in-house processes. Works with team to increase efficiencies, safety, and communication. Performs daily operations activities including refining oil, manufacturing bar soap, boiler operations, stocking supplies, and equipment troubleshooting and maintenance.



Synteract

• United States
• Biotechnology Research
• 100 - 200 Employee

• Vendor Management Specialist

  • Jul 2018 - Feb 2020

  Builds solid relationships with vendors to ensure reliable supply of necessary products and services. Collaborative efforts to streamline processes and supply chain success. Troubleshoot and resolve delays, quality concerns, and define departmental/corporate requirements and expectations.

• Quality Assurance Specialist

  • Dec 2014 - Jul 2018

  Work with internal and external team members/customers to implement and support the Quality Management System.Manage the Vendor Database with current vendor status, documentation, and contact information.Perform on-site and remote vendor audits.Assist internal team members with the CAPA and Deviation processCreate and revise SOPs and Work InstructionsHost clients and Inspection Agencies during on-site audits, including the FDA



Sendx Medical, Inc.

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Supervisor

  • Jul 2011 - Dec 2014

  Quality Assurance Supervisor overseeing QC testing and final product release. Manage 10-12 inspectors including hourly and salaried staff. Provide general support and guidance to operations staff with regards to deviations, processes, and procedures. Participate in critical meetings: MRB, CAPA, and Kaizen events Work closely with cross functional teams: Engineering, Operations, R&D Quality Assurance Supervisor overseeing QC testing and final product release. Manage 10-12 inspectors including hourly and salaried staff. Provide general support and guidance to operations staff with regards to deviations, processes, and procedures. Participate in critical meetings: MRB, CAPA, and Kaizen events Work closely with cross functional teams: Engineering, Operations, R&D



GenVault Corporation

• Biotechnology
• 1 - 100 Employee

• QA Specialist III

  • Aug 2007 - Jun 2010

  Create batch records, procedures, and validation documentation. Inspect incoming materials and outgoing final products. Perform DNA retrieval testing Review completed batch records and assemble products, as necessary Create batch records, procedures, and validation documentation. Inspect incoming materials and outgoing final products. Perform DNA retrieval testing Review completed batch records and assemble products, as necessary



Sigma-Aldrich

• Biotechnology Research
• 700 & Above Employee

• Process Development Associate III

  • 2007 - 2007

  Perform developmental cell culture procedures for pharmaceutical products using a variety of process equipment.

• Quality Assurance Associate III

  • Aug 2005 - 2007

  Review batch records and release clinical pharmaceuticals manufactured for contractual clients. Perform line clearances for production suites and ensure proper materials and equipment are available for the given process.Provide guidance and support for internal and external team members.Participate in client meetings to review results and discuss process changes and modifications.



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Lead Manufacturing Associate

  • 2002 - 2005

  Manufacture clinical pharmaceutical products in large scale production reactors. Work with cross functional teams to introduce new products and processes into the clinical manufacturing areas, including equipment preparation and document creation, as well as test runs to verify scale up capabilities. Perform sample collection and testing, equipment cleaning (CIP/SIP) and assist with cleaning and equipment validation Manufacture clinical pharmaceutical products in large scale production reactors. Work with cross functional teams to introduce new products and processes into the clinical manufacturing areas, including equipment preparation and document creation, as well as test runs to verify scale up capabilities. Perform sample collection and testing, equipment cleaning (CIP/SIP) and assist with cleaning and equipment validation



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Manufacturing Associate II

  • Mar 2001 - May 2002

  Commercial upstream manufacturing operator focusing on large scale mammalian cell culture. Processes performed include scale up cell growth from spinner culture to large scale bioreactors, inoculations, harvesting, & CIP and SIP of vessels and lines. Commercial upstream manufacturing operator focusing on large scale mammalian cell culture. Processes performed include scale up cell growth from spinner culture to large scale bioreactors, inoculations, harvesting, & CIP and SIP of vessels and lines.