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Sound Transit

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Oxford, Ohio

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Maryville, Tennessee

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Santa Rosa, California

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Silver Spring, Maryland

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Senior Quality Compliance Auditing Specialist - GLP/21 CFR Part 58 Audits (Corporate Quality)
  The Sr. Quality Compliance Auditing Specialist will be responsible for conducting internal and external non-clinical audits (in-vitro and in-vivo) on safety and biocompatibility studies to ensure conformance to 21 CFR Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies), ISO standards, and SOPs. Key Responsibilities: Conduct audits including complex assessments, to ensure conformance with applicable regulations and Edwards policies and procedures Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of non-conformance findings Provide input and may lead projects, based on understanding of standards a


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