GLP QA Auditor – Nonclinical Studies

Actalent; South Brunswick (NJ); Vor Ort; USD 55.000 - 69.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Paid Time Off

Zusammenfassung

Actalent seeks a Quality Assurance Auditor to support GLP compliance across nonclinical laboratory studies in a contract research environment. You will audit regulated studies, inspect facilities, and assist regulatory readiness for FDA and EPA inspections, contributing to cancer research and device-related testing.

The role requires 2+ years in GLP settings and 3+ years auditing GLP studies, with strong data integrity and documentation skills.

Qualifikationen

• Minimum 2+ years in a GLP-regulated environment.
• At least 3+ years auditing GLP studies and data in nonclinical labs.
• Direct CRO/toxicology/pharma/medical device lab experience.
• Experience reviewing laboratory docs for accuracy and compliance.
• Exposure to ISO standards relevant to lab/medical device testing.

Aufgaben

• Perform QA activities per FDA/EPA GLP regulations for nonclinical studies.
• Conduct in-process inspections to verify adherence to protocols and GLP requirements.
• Inspect facilities to assess compliance and identify improvements.
• Monitor study conduct ensuring alignment with approved protocols and quality standards.
• Maintain audit schedules, inspection plans and QA documentation.
• Support investigations by documenting findings and tracking actions.
• Audit raw data, lab records, notebooks and supporting documents for traceability.
• Review study reports to confirm alignment with source data and documentation requirements.
• Compare final reports against source docs to verify data integrity.
• Verify documentation complies with protocols and SOPs before final approval.
• Assist during regulatory inspections by preparing materials and responding to requests.
• Gather and organize documentation for auditors and inspectors.
• Maintain organized QA files and records for internal/external review.
• Support inspection readiness and quality system maintenance.
• Participate in continuous improvement to strengthen compliance.
• Review and control SOPs to reflect current practices and regulatory expectations.
• Maintain quality records and audit documentation per practices.
• Ensure records are complete, accurate, and inspection-ready.
• Support quality systems documentation and retention activities.
• Collaborate with lab teams on toxicology and medical device studies.
• Understand workflows for medical device testing and data extraction needs.
• Work with GLP in vitro studies and genetic mouse toxicology to understand design/documentation.
• Utilize cell culture techniques and fluorescence microscopy in data auditing.

Kenntnisse

GLP environment

GLP auditing

CRO experience

FDA GLP regulations

Data integrity

Inspection readiness

Cross-functional teamwork

Animal studies

Documentation review

Data review

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

Actalent seeks a Quality Assurance Auditor to support GLP compliance across nonclinical laboratory studies in a contract research environment. You will audit regulated studies, inspect facilities, and assist regulatory readiness for FDA and EPA inspections, contributing to cancer research and device-related testing.

The role requires 2+ years in GLP settings and 3+ years auditing GLP studies, with strong data integrity and documentation skills.