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

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

Job summary

Ardena, a Somerset, NJ-based QA Officer (QA Specialist), is seeking a hands-on quality assurance professional to support CRO operations. The role involves audits, documentation reviews, and ensuring regulatory compliance across laboratory and project activities.

You will help maintain quality systems, drive continuous improvement, and collaborate with lab, operations, and cross-functional teams to keep data integrity and regulatory readiness at the forefront of project delivery.

Qualifications

• Bachelor's degree in Life Sciences or related field; QA experience preferred.
• 3–5 years in GLP/GCP/GxP or regulated QA environments.
• Experience conducting audits, inspections, and quality reviews.

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 docs and tracking actions.
• Apply GLP, GCP, ISO, and GxP requirements when reviewing quality records and supporting audits.
• Maintain and support the Quality Management System in line with regulatory requirements.
• Assist regulatory inspections and sponsor audits with preparation and response coordination.
• Collaborate with laboratory, operations, and cross-functional teams to mitigate quality risks.

Skills

Attention to detail

Regulatory interpretation

Analytical skills

Communication

Independent work

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Electronic Quality Management System

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.

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