QA Auditor II

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Conduct and/or oversee audits and regulatory inspections for clients, internal teams, GCP, designated sites, facilities, vendors, and subcontractors.

• Offer GCP consultation and support to project teams as well as external clients.

• Act as a co-auditor during complex system audits.

• Execute QA activities such as database audits, clinical study report audits, sample results table audits, and process enhancements.

• Function as a subject-matter expert in QA and auditing for operational departments.

• Prepare and deliver presentations on audit findings and related information during departmental, internal operations, and client meetings.

• Operate in office, laboratory, and/or clinical settings.

• Manage potential exposure to biological fluids, infectious organisms, and electrical office equipment while utilizing the necessary personal protective equipment.

• Adapt to varying demands, changing conditions, physical activity, and frequent interactions with diverse groups.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• A minimum of 2 years of prior QA experience.

• Equivalence through a combination of suitable education, training, and/or directly related experience may be deemed adequate.

• Comprehensive knowledge of GCP and applicable regional research regulations and guidelines.

• Skillful in leading project-based or internal audits as well as vendor audits.

• Exceptional oral and written communication abilities.

• Strong skills in problem solving, risk assessment, and impact analysis.

• Experience in conducting root cause analysis.

• Proficient in negotiation and conflict management.

• Capability to multitask and prioritize competing demands/workloads.

• Possession of a valid driver's license.

• Capability to qualify for and sustain a corporate credit card with an adequate credit line for business travel.

• Proficient in accessing and utilizing both in-house and off-the-shelf computer software.

• Regular and consistent attendance is required.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• A workplace focused on scientific excellence.