Thermo Fisher Scientific is looking to solve the problem of ensuring quality and accuracy in clinical research through audits and regulatory inspections, enabling customers to make the world healthier, cleaner and safer.
Requirements
- Detailed knowledge of GxP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
- Strong problem solving, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Above average negotiation and conflict management skills
- Ability to use and learn standard office equipment and technology with proficiency
Responsibilities
- Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
- Leads directed site audits, facility, vendor and/or sub-contractor audits
- Provides GxP consultation and support to project teams and external clients
- Leads process audits and may participate as a co-auditor in more complex system audits
- Performs 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
- Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings
Other
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’)
- Excellent oral and written communication skills
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
