Senior / Auditor, Quality Assurance (Contractor) - San Antonio - Office-based
- Works with the QA Management to plan, conduct and complete written reports for each audit assigned.
- Monitors the projects and audit status in assigned areas and provides status reports.
- Assists with the management of the Vendor Audit program.
- Facilitates sponsor audits/regulatory inspections.
- Assists with review of audit reports to identify improvements that enhance the quality and clarity of the reports.
- Identifies areas for process improvement and provides this information to management.
- Assists with corrective and preventive action plans (CAPAs) to assure follow-up and implementation of corrections for internal and external audits.
- Provides advice and guidance on regulatory requirements and SOPs.
- Assists with training and mentoring of less experienced auditors.
- Assists with creating and presenting GCP/GLP and other related training sessions.
- Assists QA Management with review of WCT policies and procedures.
- Oversees the maintenance of records for each audit.
- Sound knowledge of applicable GCP regulations and requirements as well as WCT policies and procedures.
- Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events.
- Ability to interact professionally and to work independently or in teams.
- Excellent oral and written skills.
- Bachelor’s Degree, preferably in Life Science.
- Minimum five (5) years’ experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, three (3) of those years must be in quality assurance auditing.
- Additional experience in a relevant area (clinical setting, laboratory) that is deemed equivalent to education may be applied in lieu of the education requirement.
- Willingness to travel .
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