Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Mark Cao

Garden Grove

Summary

Highly motivated and professional employee with strong productive and administrative experience. Strong sense of teamwork. Self-directed initiative, organizational and recordkeeping skills, and attention to detail. Consistent history of exercising good judgement to contribute to efficient in operation.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Business Analyst

Edwards LifeSciences
05.2024 - Current
  • Working knowledge and implement Edwards Quality System, policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
  • Perform incorporation of approved changes to documentation (e.g
  • Ignite and PTC data entry and verify correct implementation)
  • Solid understanding of ePAC Part Attribute Control process
  • Review of documents under change process and process ePAC requests
  • Review, update and process ePAC & JDE procedures interact with departments to complete the change package, and release final change package
  • Prepare and upload electronic documentation for ECR and in JDE
  • Update systems when approvals are received & verify correct implementation of the changes
  • Collaboration with intercompany departments to process assigned tasks and requests
  • Participate in special projects, complete assigned tasks and deliverables
  • Maintain processes and procedures (e.g., SOPs, work instructions) for applicable Supply Chain functions
  • Assist in training off site-specific general procedures and EH&S, as well as on global supply chain training to new employees
  • Previous experience working with a Learning Management System
  • Actively participated in team meetings to share knowledge, exchange ideas, address challenges, and collaborate on potential solutions.

Data Analyst

Edwards LifeSciences
01.2022 - 02.2024
  • Supported daily production activities, work schedules and documentation such as SOPs, cGMP and training records
  • Prepared daily ePAC reports of Data Operation
  • Collaborate with team to establish a clean baseline for data needed to integrate ePAC Distribution Control System with JDE ERP system
  • Establish regular targets for data collection and initiation of change requests
  • Data Collection for the identified data elements that are in Edwards defined Scope
  • Support and coordinate training by preparing/processing materials, presentation, and follow-up documents
  • Complete the data collection for ePAC Part requests for any discrepant or missing Regulatory and Distribution
  • Processed ePAC Part Attribute Control, manage InterPlant Transfer Requests
  • Coordinate, collaboration in cross-functional, inclusive team-based environments
  • Evaluate changes proposed by initiators and provide feedback
  • Assist with FT Edwards employees in analysis on root cause and corrective actions for distribution issues
  • Enter and maintain all pertinent numeric and alpha data into distribution systems and other databases
  • Maintain and audit records for completeness and accuracy
  • Create and maintain processes and procedures (e.g., SOPs, work instructions) for applicable functions
  • Other incidental duties assigned by Leadership Support projects of diverse scope (e.g., process improvements), as needed
  • Train new team members
  • Performs special projects and other duties as assigned

Data Entry Clerk

Edwards LifeSciences
06.2019 - 01.2022
  • Processed, tracked and maintained training and certification records both electronically and hard copy in compliance to ISO and FDA regulatory requirements
  • Assist in training on site-specific general procedures and EH&S, as well as on global production training
  • Support and coordinate training by preparing/processing materials, presentation, and follow-up documents
  • Ensure manufacturing training and certifications are completed within time requirements by frequently reviewing training status of all employees in LMS
  • Process, track and maintain training and certification records both electronically and hard copy in compliance to ISO13485 and FDA Part 820 regulatory requirements
  • Prepared training documentation for both Read and Review methods of training
  • Entered data and training records into manufacturing
  • Entered and maintained all pertinent numeric and alpha data in to manufacturing systems, (e.g, manufacturing operations performance database, training database)
  • Support to Quality inspections, Batch processing, and Production assembly operation
  • Reviewed discrepancies in data received, requests clarification or advises supervisor on issues related to data, and performs data verification routines in accordance with procedures
  • Prepare training documentation for both Read and Review and On The Job (OJT) methods of training

Education

Business and Public Administration -

Golden West College
Huntington Beach, CA
01.2019

Liberal Arts and Science -

Golden West College
Huntington Beach, CA
01.2019

Accounting -

University of Houston
Houston, TX
01.2007

Skills

  • Data analysis
  • Data entry
  • Team collaboration
  • Microsoft Excel
  • Microsoft Word
  • Data accuracy
  • Data cleaning
  • Accuracy and attention to detail
  • Fast typing speed
  • Analytical problem solving
  • Workflow Analysis
  • Independent worker
  • KPI tracking
  • Data validation
  • Filing and data archiving
  • Office administration
  • Administrative support
  • Strong work ethic

Certification

  • Business Information Worker
  • Microsoft Office Specialist – Word 2016
  • Microsoft Office Specialist – Excel 2016

Timeline

Business Analyst

Edwards LifeSciences
05.2024 - Current

Data Analyst

Edwards LifeSciences
01.2022 - 02.2024

Data Entry Clerk

Edwards LifeSciences
06.2019 - 01.2022

Liberal Arts and Science -

Golden West College

Accounting -

University of Houston

Business and Public Administration -

Golden West College

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