Position Title: Quality Assurance Assistant

Location: 2911 Dow Avenue, Tustin CA 92780

Reports to: QA and Regulatory Officer

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Summary/Contribution of Position:

The purpose of this position is to support the quality assurance activities related to the development and manufacture of products.

Essential Duties and Responsibilities:
  • Assist QA department in the drafting, planning, and implementation of all quality programs, projects, processes and/or activities to ensure products/services are ISO9000 compliant
  • Assist the QA department for adherence to all laboratory procedures and policies, while performing oversight functions and reviews of laboratory operations
  • Manage or assist with the management of equipment qualification, calibration, and maintenance programs
  • Review procedures, protocols and other technical documents to ensure correct format and proper template usage
  • Implement governed CAPA derived from nonconformance reports, assist with internal/external audits and facility inspections
  • Complete required quality questionnaires from customers as needed
  • Assist the QA department with all customer audits and inspections
  • Assist with ISO9000 certification and customer audits
  • Conduct internal audits in conjunction with QA department
  • Assist with Design Control by collaborating with product developers
  • Participate in Management Review meetings
  • Participate in weekly QA remediation meetings
Education and Experience:
  • BA/BS degree in a science discipline preferred
Required Skills/Abilities:
  • Strong interest in Quality Assurance required
  • Some laboratory experience preferred
  • Proficiency in Microsoft Word and Excel
  • Demonstrated professional integrity with confidential information
  • Self-motivated
  • Detail oriented
  • Adaptable
  • Ability to solve problems analytically, creatively and collaboratively
  • Strong interpersonal and organizational skills
  • Willingness to learn new things
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