Clinical Auditing Specialist III

Work Schedule

Environmental Conditions

Job Description

Join Us as a Clinical Auditing Specialist III

The Clinical Auditing Specialist 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 Clinical Auditing Specialist III may perform technical document reviews and other GxP activities in support of project work or company processes including activities associated with equipment qualification validation calibration and metrology programs. Additionally the Clinical Auditing Specialist III provides finished audit reports to management plans and delivers billable quality services for clients and projects and may serve as the client contact.

What Youll Do

• Conduct and/or lead a variety of client internal or GxP audits and regulatory inspections as requested by senior management.
• Lead 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 such as database audits clinical study report audits sample results table reviews and process improvement activities.
• Serve as a resource to operational departments on audit and quality assurance subject matter.
• Provide mentorship and guidance to junior auditors.
• Conduct or support audits of validation and qualification programs including the lifecycle management of facilities utilities laboratory systems and equipment.
• Assess compliance of equipment qualification activities including installation operational and performance qualification (IQ/OQ/PQ) as applicable.

Education & Experience Requirements

• Bachelors 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.
• Experience working with or auditing equipment qualification validation calibration/metrology and/or equipment maintenance programs within a regulated GxP environment.
• Experience reviewing technical documentation such as validation protocols and reports qualification documentation calibration records equipment maintenance records deviations change controls and CAPAs is preferred.
• Experience within regulated laboratory clinical pharmaceutical biotechnology medical device or other GxP environments involving controlled equipment and measurement systems is desirable.

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 Abilities

• Detailed knowledge of GxP and appropriate regional research regulations and guidelines.
• Demonstrated proficiency in leading a range of project-based or internal GxP audits and vendor audits to the high standards required by management.
• Understanding of equipment lifecycle controls including equipment selection commissioning qualification calibration preventive maintenance change control periodic review and decommissioning.
• Understanding of risk-based approaches to validation qualification calibration and equipment lifecycle 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/workload.
• Valid drivers 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 clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office and laboratory equipment.
• Personal protective equipment may be required such as protective eyewear garments and gloves.

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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.