Clinical Auditing Specialist II - Vendor and Information System Audits Team

Thermo Fisher Scientific • Wilmington, NC

32d

About The Position

Join us as Quality Assurance Auditor II (Technology Solution Audits Team) and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards. What You’ll Do: Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management Perform directed site audits, facility, vendor and/or sub-contractor audits Provide GxP 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) Serve as a knowledgeable 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 Education and Experience: 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 2+ years’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Thorough 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 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 QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• Thorough 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
• 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

Responsibilities

• Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
• Perform directed site audits, facility, vendor and/or sub-contractor audits
• Provide GxP 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)
• Serve as a knowledgeable 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

What This Job Offers

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