BioPharma Compliance Auditor: Data Integrity & Inspection Readiness

Eurofins; West Point (PA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

Life Insurance

Disability Insurance

401(k) with match

Paid vacation & holidays

Bonus eligibility

Job summary

Eurofins PSS in the United States seeks a Compliance Specialist to support Regulatory Bioanalytical and Laboratory Operations through audits of records, data systems, and processes. You will ensure compliance with regulatory requirements, quality standards, and data integrity while maintaining audit documentation and preparing records for inspections.

This full-time role emphasizes trend analysis, corrective actions, and cross-functional collaboration to improve quality systems.

Qualifications

• Bachelor's degree in a scientific, engineering, quality, regulatory, or related discipline.
• Experience in quality assurance, compliance, auditing, laboratory operations, or regulated environments.
• Knowledge of regulated laboratory environments and data integrity principles.
• Strong documentation review and record management skills.
• Experience preparing reports, compliance metrics, and audit findings.
• Must be eligible to work in the United States indefinitely without restriction or sponsorship.
• Experience in bioanalytical, pharmaceutical, biotechnology, or regulated research environments.
• Familiarity with regulatory inspection readiness activities.
• Working knowledge of GxP principles, quality systems, and accreditation requirements.
• Experience supporting internal audits and compliance reviews.

Responsibilities

• Audit scientist and engineer records for completeness, accuracy, and appropriateness.
• Audit bioanalytical data records, laboratory systems, and related documentation.
• Prepare audit-ready records and documentation packages for reviews.
• Monitor compliance trends and identify emerging risks.
• Support regulatory inspections and prepare documentation and responses.
• Track audit completion against schedules and procedures.

Skills

Quality assurance

Auditing

Regulatory compliance

Data integrity

Documentation

Communication

Education

Bachelor's degree in science/regulatory

Job description

Eurofins PSS in the United States seeks a Compliance Specialist to support Regulatory Bioanalytical and Laboratory Operations through audits of records, data systems, and processes. You will ensure compliance with regulatory requirements, quality standards, and data integrity while maintaining audit documentation and preparing records for inspections.

This full-time role emphasizes trend analysis, corrective actions, and cross-functional collaboration to improve quality systems.