Quality Assurance Specialist - GLP/GCP Audits

Ardena; New Jersey; On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Flexible working arrangements

Global multi-site collaboration

Professional development

Job summary

Ardena, Somerset (US), is seeking a QA Officer (QA Specialist) to provide hands-on quality assurance support for CRO operations. You will conduct audits, review quality documents, and support inspections to ensure regulatory compliance and data integrity across lab and project activities.

Join a fast-paced CRO environment focused on continuous quality improvement and cross-functional collaboration with laboratory and operations teams.

Qualifications

• Bachelor’s degree in Life Sciences or related field and quality assurance experience.
• 3–5 years experience in GLP, GCP, GxP or regulated quality systems.
• Experience conducting audits, inspections, quality reviews.

Responsibilities

• Conduct and document audits of study, facility, process, vendor, internal, client, sponsor, and regulatory activities.
• Review SOPs, protocols, reports, records, and quality statements.
• Support CAPA, deviation investigations, change control, and corrective actions.
• Apply GLP, GCP, ISO, and GxP requirements when reviewing quality records and supporting audits.
• Maintain the Quality Management System and assist regulatory inspections and sponsor audits.

Skills

Attention to detail

Regulatory interpretation

Analytical thinking

Communication skills

Independent worker

Audits & inspections

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Electronic QMS

Job description

Ardena, Somerset (US), is seeking a QA Officer (QA Specialist) to provide hands-on quality assurance support for CRO operations. You will conduct audits, review quality documents, and support inspections to ensure regulatory compliance and data integrity across lab and project activities.

Join a fast-paced CRO environment focused on continuous quality improvement and cross-functional collaboration with laboratory and operations teams.