Quality Assurance Specialist - GLP/GCP Audits & Compliance

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

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