Pharma Compliance Auditor – Bioanalytical QA

Eurofins; West Point (PA); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Bonus opportunities

Job summary

Eurofins USA PSS is seeking a Compliance Specialist to support Regulatory Bioanalytical and Laboratory Operations by conducting quality and compliance audits of records, data systems, and processes. You will maintain audit documentation, generate compliance trend reports, and assist in inspections.

The role emphasizes adherence to regulatory requirements, data integrity, and continual improvement across the department, with a Monday–Friday 1st shift in a full-time capacity in West Point, PA.

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.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.

Responsibilities

• Conduct audits of scientist and engineer records to ensure completeness, accuracy, and appropriateness.
• Perform cross-checks against source documentation and analyze selected data elements for compliance and integrity.
• Audit bioanalytical data records, laboratory systems, and associated documentation.
• Assess adherence to quality standards, regulations, policies, procedures, and accreditation requirements.
• Maintain detailed audit records and documentation supporting audit findings.
• Prepare and organize audit-ready records and documentation packages for management reviews, project reviews, and internal audits.
• Support regulatory and accreditation surveys by preparing documentation, facilitating responses, and coordinating follow-up actions.
• Assist in maintaining inspection readiness across the department.
• Monitor compliance trends and identify emerging risks.
• Develop audit summaries and trending reports to communicate compliance performance.
• Analyze findings and identify opportunities to improve quality, efficiency, and data integrity.
• Prepare recommendations for corrective and preventive actions.
• Track audit completion against established schedules and procedures.
• Support continuous improvement initiatives related to quality systems and record management.
• Audit broader departmental processes including: Training compliance, Timekeeping accuracy, Policy and procedure management, Laboratory development plans and assessments, Regulatory record maintenance, Ensure compliance documentation remains current, complete, and inspection ready

Skills

Quality assurance

Auditing

Documentation review

Regulated environments

Regulatory reporting

Attention to detail

Communication skills

Education

Bachelor's degree in a scientific/engineering/regulatory field

Job description

Eurofins USA PSS is seeking a Compliance Specialist to support Regulatory Bioanalytical and Laboratory Operations by conducting quality and compliance audits of records, data systems, and processes. You will maintain audit documentation, generate compliance trend reports, and assist in inspections.

The role emphasizes adherence to regulatory requirements, data integrity, and continual improvement across the department, with a Monday–Friday 1st shift in a full-time capacity in West Point, PA.