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RxCloud

Quality Engineered and Compliance Assured

GxP Auditor

AuditorAuditorFull TimeRemoteLeadTeam 11-50Since 2020H1B SponsorCompany SiteLinkedIn

Location

Oregon

Posted

115 days ago

Salary

0

Seniority

Lead

Bachelor Degree20 yrs expEnglish

Job Description

GxP Auditor

RxCloud

• Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations. • Develop and implement the global audit strategy, aligning with organizational goals and regulatory requirements. • Perform audits across various departments and functional areas. • Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures. • Review and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes. • Collaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved. • Conduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues. • Prepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders. • Responsible for leading, conducting, and documenting investigations relating to audit findings noted internally. • Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings. • Ensure audits are performed within budget and according to plan. • Facilitate post-audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings. • Produce draft and final versions of audit plans, reports and summaries within defined timeframes and accordance with internal policies / procedures. • Promote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services. • Stay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.

Job Requirements

  • Minimum bachelors degree in any scientific discipline.
  • A minimum of 20 years of relevant experience including a minimum of 15 years of GxP. auditing in a regulated environment focused on quality.
  • Excellent knowledge of GxP regulatory requirements.
  • Experience using electronic Quality Management Systems.
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Ability to understand when issues require escalation to Senior Quality Management.
  • Must be detail oriented; must be precise and organized in handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.

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