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QA Program Manager - Quality Sytems

Company: Bachem
Location: Torrance
Posted on: June 15, 2019

Job Description:

Your Tasks

  • Develop metrics for Quality Systems in support of management review and various quality reports
  • Assist with creation of shared Quality Systems documents for Bachem Americas sites to achieve harmonization
  • Assist with implementation of different modules of Master Control software at Bachem US
  • As part of the Central Function Quality System team you may be required to assist with maintenance/oversight of some of the following Quality Systems:
  • Quality Event Reporting
  • Document Management System
  • Change Control/Equipment Change Control
  • Data integrity program
  • Supplier Quality program
  • Material Qualification Program
  • Internal audit program
  • External audit program
  • Annual Product Review Your Profile Required:
    • Bachelor's Degree in a science related field - Chemistry, Biology or equivalent
    • Minimum of 5 to 8 years of experience in quality assurance
    • Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance
    • Experience in writing standard operating procedures, specifications and technical reports
    • Experience conducting audits
    • Experience with the Material Qualification process
    • Experience in developing quality system metrics
    • Technical writing experience
    • Excellent written and oral communication skills
    • Excellent computer skills, including Microsoft Word, Excel and PowerPoint and Access
    • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
    • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
    • Detail oriented with the ability to troubleshoot and resolve problems
    • Ability to work independently and manage one's time
    • Ability to interact well with co-workers, customers, regulatory agency auditors and senior management
    • Communicate effectively and ability to function well in a team environment Preferred:
      • Master's Degree in Science related field
      • Experience with Master Control or other electronic quality management system
      • Lean or six-sigma Green and/or Black belt certification

Keywords: Bachem, Los Angeles , QA Program Manager - Quality Sytems, Executive , Torrance, California

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