GCP QA Auditor III
Thermo Fisher
Summary
The Quality Assurance Auditor III leads complex and/or multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This role identifies issues impacting quality and regulatory compliance, determines the root cause of non-conformance, and develops strategies to address these issues. The Quality Assurance Auditor III may perform technical document reviews and other GCP activities in support of project work or company processes. Additionally, the Quality Assurance Auditor III provides finished audit reports to management, plans and delivers billable quality services for clients and projects and may serve as the client contact.
Job description
What You'll Do
- Conduct and/or lead a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
- Lead directed site audits, facility, vendor and/or sub-contractor audits
- Provide GCP consultation and support to project teams and external clients
- Lead process audits and may participate as a co-auditor in more complex system audits
- Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
- Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matter
- Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
- Provide mentorship and guidance to junior auditors
Education & Experience Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous GCP QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years')
Knowledge, Skills, Abilities
- Detailed knowledge of GCP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high 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
- Flexible and able to multi-task and prioritize competing demands/work load
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous GCP QA experience comparable to 5+ years
- Detailed knowledge of GCP and appropriate regional research regulations and guidelines
- Demonstrated proficiency leading project based or internal GCP audits and vendor audits
- 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
- Flexible and able to multi-task and prioritize competing demands/work load
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.