QA Officer CRO/Senior QA Officer (QA Specialist Bioanalytics)

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. 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

• 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.
• Apply applicable GLP, GCP, ISO, and GxP requirements when reviewing quality records, supporting audits, and monitoring compliance activities.
• Maintain and support the Quality Management System in accordance with regulatory requirements, company standards, and approved procedures.
• Support regulatory inspections and sponsor audits through preparation, documentation review, response coordination, and follow-up on assigned actions.
• Collaborate with laboratory, operational, and cross-functional teams to identify quality risks, resolve quality-related issues, and promote continuous improvement.
• Support quality training programs and help promote awareness of quality, compliance, documentation integrity, and data integrity requirements.

Qualifications

• Bachelor’s degree in Life Sciences, Biology, Microbiology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline; equivalent education and relevant quality assurance experience may be considered.
• 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.

Skills and Attributes

• Strong attention to detail with a commitment to documentation integrity and data integrity.
• Ability to interpret regulations, procedures, technical documents, and quality standards.
• Strong analytical, problem-solving, planning, organization, and time management skills.
• Effective written and verbal communication skills, including report writing and cross-functional collaboration.
• Ability to work independently and collaboratively in a regulated laboratory and project environment.
• Professional, objective approach to aud