Nancy Le

QA Specialist IV, Computer Systems Validation at Ardelyx

Nancy Le has a diverse work experience in various companies and industries. Nancy started their career as a Leasing Administrator at Irvine Company from November 2013 to February 2015. After that, they worked as a QA Validation Specialist at Coherus BioSciences from March 2015 to December 2015, where they reviewed batch records and ensured data integrity.

From December 2015 to April 2018, Nancy worked at Boehringer Ingelheim as a QA Validation Specialist, focusing on preparing and executing cleaning validation for drug products. Nancy also developed protocols and provided supervision during manufacturing validation execution.

Nancy then joined Genentech in April 2017 as a Validation Engineer. In this role, they demonstrated an in-depth understanding of System Development Life Cycle (SDLC) documentation for Commissioning & Qualification execution. Nancy authored deliverables, including system impact assessments, user requirements specifications, and commissioning protocols.

From February 2015 to June 2019, Nancy worked as a Pharmaceutical Validation Consultant at Hyde Engineering + Consulting. During their time there, they provided expertise in pharmaceutical validation for various projects.

In September 2019, Nancy joined Intarcia Therapeutics, Inc. as a QA Validation Engineer. Nancy supported the maintenance of GxP equipment, computer systems, and QC laboratory systems in a qualified state. Their responsibilities included reviewing validation documentation, managing contract personnel, and developing and reviewing protocols, reports, and data tables.

Most recently, Nancy has been working at Ardelyx, Inc. since May 2020 as a QA Specialist IV, Computer Systems Validation. Further details about this role, such as the specific responsibilities and end date, were not provided.Overall, Nancy Le has a strong background in QA validation and a wide range of experience in the pharmaceutical and biotech industries.

Nancy Le holds a Bachelor of Science (B.S.) degree in Health Sciences/Public Health from California State University, Los Angeles. The specific start and end years of their education are not mentioned.

Links

Previous companies

Boehringer Ingelheim logo
Irvine Company logo
Coherus BioSciences logo
Intarcia Therapeutics logo
Genentech logo

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Timeline

  • QA Specialist IV, Computer Systems Validation

    May, 2020 - present

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