GCP QA Clinical Auditor II

Thermo Fisher Scientific

13h • Onsite

About The Position

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

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’). 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.
• 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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

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