QA Officer CRO/Senior QA Officer (QA Specialist Bioanalytics)
Ardena Careers
RemoteFull timeMid levelPosted today
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Ardena Careers
About Ardena Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.
The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.
For the Ardena Business Unit based in Somerset (US), we are looking for a [Job Title]
Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.
Job Overview Position: QA Officer (QA Specialist)
Department: Quality Assurance
Location: Somerset (US)
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.
In this fast-paced, client-focused Contract Research Organization environment, the QA Officer will help maintain quality systems, support continuous improvement, and partner with laboratory, operational, and cross-functional teams to ensure quality, data integrity, and regulatory compliance remain central to successful project delivery.
Key Responsibilities
Qualifications
Skills And Attributes
Work Environment This role is performed in a combination of office, laboratory, and operational environments. The position may require periodic presence in laboratory areas where appropriate PPE is required, as well as occasional work outside standard business hours or travel to support audits, inspections, investigations, training, client visits, or regulatory activities.
What Ardena Offers Ardena is a global CDMO and bioanalytical CRO supporting complex drug development programs across Europe and the United States. At Ardena, our WE CARE values guide how we work: We lead with innovation, Enhance the lives of patients, Communicate clearly, take Accountability, remain Reliable, and pursue Excellence. This is an opportunity to contribute to meaningful scientific work while helping strengthen a culture of quality, compliance, operational excellence, and continuous improvement.
Benefits and perks at Ardena include:
Salary Range: $75,000 - $90,000 How To Apply Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.