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
- Adaptable and able to multi-task and prioritize competing demands

📌 GCP QA Clinical Auditor II (Colombia)
🏢 ThermoFisher Scientific
📍 Colombia