Jessica Claire
Montgomery Street, San Francisco, CA 94105 (555) 432-1000,
Experienced Lead Auditor with plenty of exposure to manufacturing of electronic, toner and paper products. My desire is to apply my years of experience in Quality Control, Production and most recently in Compliance Assurance auditing department to benefit my new job. I’m also proficient in my understanding of the new requirements of the ISO Standards 9001, 14001 and 27001.

Lead the organization to achieve Quality & Environmental ISO certifications.

to Specialist- Compliance Lead Auditor Spectrum Health | , ,
  • Lead auditor responsible for audit planning, assessing audit risks, selecting audit team and executing the internal audits throughout the organization.
  • Responsible and following up on findings.
  • Achievement = Maintain audit certifications on an annual basis by co-coordinating external surveillance and recertification audits and achieving 100% completed on schedule and no conflicts.
  • Lead the Quality System harmonization activities and manage CAPA process by communicating closely with CAPA owners and fully understand root cause methodologies.
  • Achievement = reduction in overall process cost and increasing CAPA process efficiency.
  • Deliver reports of internal audit program with value added opportunities for improvement with over 95% effectiveness of actions taken.
  • System Administrator responsible for implementing and managing the Quality System International (QSI), a third party software designed to meet ISO Standards.
  • Achievement = deployed 7 essential databases in QSI that constitute the majority of production provisions such as CAPA, management review, document control etc.
  • Assume full responsibility for all ITGC (IT General Controls) SOX audits, planning, executing and reporting audits results.
  • Act as the main liaison in communicating with External auditors.
  • Achievement = Managed to increase the reliability of internal testing by 20% which resulted in reducing external audit time with total saving of over $50,000 annually.
to IT Governance - Management System Specialist | , ,
  • Collaborate with and lead the ISMS project team to establish, implement and document the Information Security Management System (ISMS) for the company.
  • Achievement = ISO 27001 certification in an extremely tight schedule within 2 months and met the company's objectives.
  • Plan, manage, and perform internal audits activities for SOX IT General Controls.
  • Achievement = Maintain compliance with access control restrictions.
  • Design & update tests paperwork for TDE (Test Design Effectiveness) & TOE (Test Operation Effectiveness) and prepare audit reports.
  • Achievement = improve efficiency, reduce non-value added time, save hundreds of hours in external audit activities.
  • Perform information security risk assessment, implement mitigation solutions.
  • Achievement = Maintain an update information assets inventory list.
  • Act as the liaison with third party external auditor to provide evidence to support effectiveness of operations.
  • Perform functions to enforce compliance relative to software changes, project management and System Development Life Cycle.
  • Responsible for establishing and maintaining policies and standard operating procedures required by the ISO Standards (9001:2015; 14001:2015; 27001:2013).
  • Achievement = established over 100 SOP to meet organizational and Standards requirements.
  • Reduced the documented information by 30% using consolidation and the process approach.
to Manager NA | , ,
  • Responsible for developing systems for the quality inspection operations and setup the quality inspection lab.
  • Achievement = Setup inspection instruments such as particle size analyzer, X-Ray, smoothness tester, release value etc.
  • Responsible for developing an effective corrective and preventative program to reduce nonconforming products.
  • Establish operating procedures for different measuring and testing equipment & train personnel on methods of calibration.
  • Achievement = Created all inspection and calibration procedures.
  • Handle the coordination with suppliers regarding raw material quality issues and collaborating with R&D, production and engineering.
  • Achievement = ensure effective resolutions of critical issues, reduced claims to meet the organization's objectives.
  • Develop excellent communication process flow between QC and production to ensure quick and accurate delivery of inspection results.
  • Achievement = minimized error gap to less than 2%.
  • Work closely with R&D to ensure proper communication of product specifications to all related departments.
Expected in Bachelor's Degree of Science | Chemistry & Math , , GPA:
Chemistry & Math Certified Lead Auditor for 9001 by a world known registrar recognized by IRCA. *Certified Lead Auditor for 14001 by a world known registrar British Standard Institute. (BSI). *Oriented to meet goals and objectives effectively and with high standards, team player and effective communicator.

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  • Specialist- Compliance Lead Auditor
  • IT Governance - Management System Specialist
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