Compliance Specialist - Pharmaceuticals

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

Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

Job Description

Position Summary

The Compliance Specialist will support Regulatory Bioanalytical and Laboratory Operations by conducting quality and compliance audits of scientist and engineer records, bioanalytical data systems, and departmental processes. This role ensures adherence to regulatory requirements, quality standards, data integrity expectations, and accreditation requirements while driving continuous improvement across departmental operations. The specialist will maintain audit documentation, prepare audit-ready records, generate compliance trend reports, and support internal and external inspections.

Key Responsibilities

Quality & Compliance Auditing

• 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.

Regulatory & Inspection Readiness

• 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.

Process Improvement & Reporting

• 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.

Departmental Compliance Support

• 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

Qualifications

Basic Minimum 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.

Preferred Qualifications

• 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.

Additional Information

This role is a full-time, permanent position Monday-Friday 1st Shift.

Excellent Full-time Benefits Include

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.