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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American Academy of Environmental Engineers and Scientists®
147 Old Solomons Island Road, Suite 303
Annapolis, MD 21401
410.266.3311 | FAX: 410.266.7653