Role Overview
Ardena is seeking a Quality Assurance Officer to provide hands-on quality assurance support for CRO operations at our Somerset, NJ site. This role is responsible for conducting and documenting audits, reviewing quality documentation, monitoring compliance with applicable regulatory standards, and supporting inspection readiness across laboratory and project activities.
What You Will Do
Conduct and document study, facility, process, vendor, internal, client, sponsor, and regulatory audits. Review quality documentation, including SOPs, protocols, reports, records, and quality statements. Support deviation, non-conformance, change control, and CAPA processes by reviewing documentation, tracking actions, and helping ensure timely closure.
Why It Might Be a Fit
This is an opportunity to contribute to meaningful scientific work while helping strengthen a culture of quality, compliance, operational excellence, and continuous improvement.
Requirements
- Bachelor’s degree in Life Sciences, Biology, Microbiology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline
- 3 -5 years experience working within GLP, GCP, GxP, or other regulated quality systems
- Experience conducting audits, inspections, quality reviews, and compliance assessments
- Knowledge of CAPA management, deviation investigations, risk assessments, and document control processes
- Experience supporting regulatory inspections and client audits preferred
- Proficiency with Microsoft Office applications and electronic Quality Management Systems
Benefits
- Competitive salary
- Tailored benefits package
- Flexible working arrangements
- Paid annual leave
- International and collaborative work environment
- Access to professional development and training programs
- Meaningful work on pharmaceutical development projects
- Values-driven culture guided by Ardena’s CARE principles
To apply for this job please visit careers.ardena.com.
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