Compliance Specialist - Pharmaceuticals

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
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.

Employment type
Full-time

Work arrangement
No