GxP Auditor

February 5

🌲 Oregon – Remote

Although this job is listed in Oregon, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🔴 Lead

🔎 Auditor

🦅 H1B Visa Sponsor

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RxCloud

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RxCloud is a leading provider of quality engineering and regulatory compliance services focused on the life sciences sector, including pharmaceuticals, biotechnology, and medical devices. With over 1000 years of combined IT and domain expertise, RxCloud specializes in offering a range of services such as GxP audits, quality management consulting, and IT systems validation. They prioritize efficiency, compliance, and innovation, helping their clients navigate the complex regulatory landscape while maintaining high quality standards in their operations.

Validation • Testing • Automation • GxP • GMP

11 - 50 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of RxCloud. • Act as a Subject Matter Expert (SME) for GxP auditing and quality projects. • Responsible for supporting the on-going development and management of the Quality Management Auditing system. • Independent management of quality/GxP auditing deliverables scheduled. • 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 to ensure audit findings are addressed and resolved. • Conduct investigations into allegations of fraud, unethical practices, or non-compliance. • Prepare comprehensive audit reports, including findings, recommendations, and action plans. • Responsible for leading, conducting, and documenting investigations relating to audit findings. • Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors. • Ensure audits are performed within budget. • Facilitate post-audit debriefs with internal stakeholders within defined timeframes. • Produce draft and final versions of audit plans, reports and summaries. • Promote continual improvement regarding stakeholder satisfaction with an emphasis on Quality/GxP auditing services. • Stay current with advances and technological changes in Quality/GxP services within the biotech industry.

🎯 Requirements

• Minimum bachelor 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.