Clinical Quality Assurance Auditor

Work Schedule

Environmental Conditions

Job Description

Join us as Clinical Quality Assurance Auditor and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

A day in the life of a Clinical QA Auditor:

• Conduct and/or lead a variety of internal and GCP audits as requested by senior management

• 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

• Provide GxP consultation and support to project teams and external clients

• Prepare and present audit findings and/or other related information at departmental internal operations or client meetings

Required Education and Experience:

• 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 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.

Required Knowledge Skills and Abilities:

• Thorough knowledge of GxP with particular expertise in GCP as well as applicable 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 drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

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 experience and where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthrough!