Compliance Specialist - Pharmaceuticals

Compliance Specialist role supporting regulatory and bioanalytical operations at a pharmaceutical laboratory. The position involves conducting quality audits, maintaining compliance documentation, preparing for regulatory inspections, and driving continuous improvement across departmental processes.

Responsibilities

• Conduct audits of scientist and engineer records for completeness, accuracy, and regulatory compliance
• Review bioanalytical data systems, laboratory records, and documentation against quality standards
• Prepare audit-ready documentation packages for inspections and management reviews
• Generate compliance trend reports and identify opportunities for quality improvement
• Support regulatory and accreditation surveys with documentation coordination and follow-up activities

Requirements

• Bachelor's degree in science, engineering, quality, regulatory, or related field
• Experience in quality assurance, compliance, auditing, or regulated laboratory environments
• Knowledge of data integrity principles and regulated laboratory operations
• Strong documentation review and record management capabilities
• Proficiency preparing reports, compliance metrics, and audit findings
• Excellent attention to detail, organizational, written, and verbal communication skills
• Eligible to work in the United States without sponsorship