GCP QA Auditor III

Thermo Fisher Scientific • Austin, TX

18h • Onsite

About The Position

The Quality Assurance Auditor III leads complex and/or multi-department internal and external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. The role identifies issues affecting quality and regulatory compliance, determines the root causes of non-conformance, and develops strategies to address them. The auditor may also perform technical document reviews and other GCP activities supporting project work or company processes.

The role provides finished audit reports to management, plans and delivers billable quality services for clients and projects, and may serve as a client contact. It also provides GCP consultation and support to project teams and external clients, serves as a quality assurance resource to operational departments, presents audit findings, and mentors junior auditors.

Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous GCP QA experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years.
• Detailed knowledge of GCP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency leading a range of project-based or internal GCP audits and vendor audits to the standards required by management.
• Excellent oral and written communication skills.
• Strong problem-solving, risk-assessment, and impact-analysis abilities.
• Solid experience in root cause analysis.
• Above-average negotiation and conflict-management skills.
• Ability to be flexible, multitask, and prioritize competing demands and workload.
• Valid driver's license.
• Ability to qualify for and maintain a corporate credit card with a sufficient credit line for business travel.

Responsibilities

• Conduct and/or lead client, internal, and GCP audits and regulatory inspections as requested by senior management.
• Lead directed site, facility, vendor, and/or subcontractor audits.
• Provide GCP consultation and support to project teams and external clients.
• Lead process audits and participate as a co-auditor in more complex system audits.
• Perform other QA audits or activities, such as database audits, clinical study report audits, sample results tables, and process improvement.
• Serve as a resource to operational departments on audit or quality assurance subject matter.
• Prepare and present audit findings and related information at departmental, internal operations, or client meetings.
• Provide mentorship and guidance to junior auditors.
• Prepare finished audit reports for management and plan and deliver billable quality services for clients and projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior