QA Auditor III (GLP)

Resolian – Your global bioanalytical, biomarker and analytical sciences partner supporting all phases of your drug development. Resolian is a leading global Contract Research Organization (CRO) providing specialized services in GxP and non-regulated bioanalysis, drug metabolism/pharmacokinetic (DMPK), and GMP CMC analytical and materials science. Its team of more than 400 experts across the US, UK, and Australia, Resolian supports pharma and biotech companies’ programs throughout the entire drug development continuum.

As a QA Advisor III, you will play a key role in ensuring the quality and integrity of data supporting GLP and GCP studies, while also helping drive continuous improvement across the organization. This is more than a traditional auditing role. It is an opportunity to influence quality culture, strengthen processes, and serve as a trusted quality partner across multiple departments.

Beyond auditing, you will serve as a trusted quality partner to operational and scientific teams by reviewing SOPs and quality system documents, evaluating compliance with applicable regulations, supporting quality events and CAPA activities, participating in vendor qualification processes, and hosting client audits. The position provides broad exposure to both study-related and systems-based quality activities, allowing you to make meaningful contributions that directly impact the success of our organization and our clients.

We are seeking an experienced quality professional who can work independently, manage multiple priorities, lead projects and meetings, mentor team members, and serve as a departmental subject matter expert. Success in this role requires sound judgment, strong communication skills, and a proactive approach to identifying opportunities for improvement and implementing practical solutions.

If you are looking for a fast-paced environment that offers continuous learning, professional growth, and the opportunity to make a meaningful impact every day, we encourage you to apply and join our growing team. No two days are alike, and the variety of responsibilities provides ongoing opportunities to develop your expertise while helping shape the future of Quality Assurance within the organization.

Requirements

Skills, Education & Qualifications

• BA/BS or higher; all experiences will be evaluated
• 6+ years experience in GxP Environment, all experiences will be evaluated
• Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP
• Prior CRO Lab Experience a plus
• Familiar with pharmaceutical or biotechnology industry
• Able to review detailed data and documents
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment