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 AuditingConduct 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 ReadinessPrepare 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 & ReportingDevelop 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 SupportAudit broader departmental processes including:Training complianceTimekeeping accuracyPolicy and procedure managementLaboratory development plans and assessmentsRegulatory record maintenanceEnsure compliance documentation remains current, complete, and inspection ready