About the role
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. * Must be eligible to work in the United States indefinitely without restriction or sponsorship.
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. Candidates currently located within commutable distance to West Point, PA are encouraged to apply.
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.