GCP QA Clinical Auditor II

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as Quality Assurance Auditor II - 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 GCP audits and regulatory inspections as requested by senior management • Perform 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) • 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 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 Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves. Physical Requirements: • Ability to work in an upright and /or stationary position for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthrough.