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Senior GCP Process Auditor
Precision For MedicineGCP Process Auditor supporting audit programs and compliance activities in clinical research. Contributing expert oversight in quality management for clinical trials at Precision for Medicine.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support the Quality Management System including SOPs, training and CAPA
- Process and maintain documentation for controlled documents, as required
- Develop and administer training for employees and/or consultants
- Host client/sponsor audits and support regulatory inspections
- Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
- Coordinate and conduct internal audits of quality systems
- Coordinate and conduct investigator site audits
- Coordinate and conduct trial master file audits
- Participate on computer systems validation projects and systems change control processes
- Provide QA consultation and support to assigned project teams internally and externally
- Support and manage reported quality issues and any associated corrective and preventive actions
- Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
- Maintain Q&C trackers, databases, metrics, and files
- Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures
Requirements
What you’ll need- The ideal candidate will have extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits - candidates without this experience cannot, unfortunately, be considered
- Working knowledge of GCP/ICH guidelines and FDA regulations and standards
- Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
- Availability to travel up to 25% domestically and/or internationally
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management SystemSOP DevelopmentCAPA ManagementAudit CoordinationDocumentation ControlGCP ComplianceRegulatory Inspection SupportInternal AuditsTrial Master File AuditsComputer Systems Validation
Soft Skills
CommunicationCollaborationProblem-SolvingAttention to DetailOrganizational Skills