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

Ardena; Franklin Township (NJ); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Flexible working arrangements

Global environment

Professional development

CARE culture

Job summary

Ardena in Somerset, NJ is seeking a Quality Assurance Officer (QA Specialist) to provide hands-on QA support for CRO operations. The role involves conducting audits, reviewing quality documentation, and ensuring compliance with GLP, GCP, and GxP standards across laboratories and projects.

The successful candidate will maintain the Quality Management System, support continuous improvement, and partner with lab and operations teams to uphold data integrity and regulatory readiness for inspections

Qualifications

• Bachelor’s degree in Life Sciences or related field; equivalent education and relevant QA experience may be considered.
• 3-5 years experience in GLP, GCP, GxP or other regulated QA systems.
• Experience conducting audits and inspections and quality reviews.
• Knowledge of CAPA management, deviation investigations, risk assessments, and document control.

Responsibilities

• Conduct and document audits of study, facility, process, vendor, internal, client, sponsor, and regulatory activities.
• Review quality documentation including SOPs, protocols, reports, records, and quality statements.
• Support deviation, non-conformance, change control, and CAPA processes; track actions and ensure timely closure.
• Apply GLP, GCP, ISO and GxP requirements when reviewing records and supporting audits.
• Maintain and support the Quality Management System in line with regulatory requirements and company procedures.
• Assist regulatory inspections and sponsor audits through preparation and response coordination.
• Collaborate with cross-functional teams to identify quality risks and promote continuous improvement.
• Support quality training and promote awareness of data integrity requirements.

Education

Bachelor’s degree in Life Sciences or related

Tools

Microsoft Office

Electronic Quality Management System (eQMS)

Job description

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

• 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 audits, inspections, quality reviews, and compliance assessments.

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:

• Competitive salary and tailored benefits package (adjusted per role and location)
• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)
• International and collaborative work environment across European and US sites
• Access to professional development and training programs
• Meaningful work on pharmaceutical development projects that advance patient health
• A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent

Salary Range: $75,000 - $90,000