QA Auditor II - III, Clinical/GCP at Thermo Fisher Scientific

• As a QA Auditor, you will conduct complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.  

Summarized Purpose: 

• Conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects.

Essential Functions:    

• 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 PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit.
• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement) 
• Serves 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 
•  Provides mentorship and guidance to junior auditors. 

Education and Experience:  

• Bachelor's degree in a life science field or equivalent qualification and relevant experience
• Auditing experience in clinical research in regulatory phase trials with high level of competency
• or Equivalent combination of education and prior directly related experience.

Knowledge, Skills and Abilities:    

• Familiar with ICH-Good Clinical Practices and appropriate regional clinical research regulations (e.g., relevant EU Regulations/Directives, EMA and other regulatory agency guidelines)
• Internal candidates must have a thorough working knowledge of PPD Clinical Standard Operating Procedures and Working Practice Documents
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Able to work independently or in a team environment
• Good problem-solving abilities
• Good organizational and time management skills
• Basic computer skills and ability to learn and become proficient with appropriate applications
• Proven flexibility and adaptability
• Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for extensive business travel.