Compliance Specialist - Pharmaceuticals
Job in
West Point, Montgomery County, Pennsylvania, 19486, USA
Listed on 2026-10-11
Listing for:
Eurofins
Full Time
position Listed on 2026-10-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
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.
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.
If you’re looking for a rewarding career, a place to call home, apply with us today!
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,…
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