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Quality Assurance Auditor

Company: Medix---
Location: Everett
Posted on: August 3, 2022

Job Description:

The Quality Assurance Auditor coordinates auditing activities to ensure compliance with SOPs and GLP requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews.Responsibilities:-Audits protocols, amendments, raw data, reports and supporting documentation for internalaccuracy, consistency, and conformance with regulations and internal SOPs-Performs phase inspections of ongoing study activities-Performs facility audits to ensure departmental compliance with the regulations-Oversees and assists with audits to assure departmental consistency-Prepares, issues, and tracks reports of observations noted during audits and inspections-Applies a thorough understanding of compliance to a broad range of regulatory issues-Maintains computerized files to support audit activities-Assists in scheduling audits and assigning resources to projects-Coordinates auditing activities and implements auditing systems to ensure compliance with GLPrequirements-Identifies, evaluates, and implements best practices-Evaluates interdepartmental processes for improvement opportunities and proposes solutions-Helps design and develop risk-managed regulatory processes-Oversees and designs training systems; acts as a lead trainer for new and junior staff-Drives project planning and implementation; acts as lead auditor on studies-Solicits and gains support of employees, clients and management through effectivecollaboration and negotiation; represents QA in workgroups-Evaluates interdepartmental processes for improvement opportunities and proposes solutions -Oversees and designs training systems; trains and qualifies trainers on internal processes andprocedures-Communicates with clients regarding regulatory issuesMust Have Skills:

  • Bachelors Degree (BS) in life sciences or related discipline
  • 2-3 years+ Auditing in GLP regulated environment Nice to Have Skills
    • RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality - Certified Quality Auditor) or other certification is recommended

Keywords: Medix---, Everett , Quality Assurance Auditor, Accounting, Auditing , Everett, Washington

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