732-661-0400

QA Auditor

  • Location: Irvine, CA
  • Type: Direct Hire
  • Job #36514

One of our Global Medical Device partners is seeking a QA Auditor to join their team! This is a great opportunity for individuals who are interested in transitioning from the bench to a more documentation focused role.

Direct hire!

Principal Duties and Responsibilities

  • Evaluate data and/or lab work to assess compliance with quality system regulations (ISO, GMP, and GLP) and SOPs.
  • Review records for accuracy, consistency, and compliance.
  • Participate in audits of facilities, suppliers and agencies.
  • Perform periodic audits of internal operations to assess internal performance and detect quality problems.
  • Determine source of quality problems and makes recommendations for improvements.
  • Assure corrective action is taken through follow up activities.
  • Assist in design of test validation programs and check sample evaluations.
  • Assists in lab qualification activities.
  • Maintain QA training manual to reflect current practices.
  • Approve client submitted test specifications in Master Control.

Qualifications and Skills

  • Bachelor’s degree in a scientific discipline
  • Requires 1-2 years experience in GLP or GMP regulated environment.
  • Strong documentation & computer skills.

 

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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