Compliance Specialist

Responsibilities

• Investigate and resolve production issues, determining root causes and implementing corrective actions
• Own and manage compliance records, including deviations, CAPAs, change controls, and events
• Ensure compliance with SOPs, cGMP, regulatory standards, and safety protocols
• Oversee quality self-inspections, develop inspection schedules, and train resources
• Conduct regular compliance audits and process confirmations
• Monitor and direct deviation teams to meet system requirements
• Provide expertise in the scale-up and transfer of new products or processes
• Perform reviews of protocols, risk assessments, and compliance records
• Apply Lean Six Sigma tools to drive continuous improvement in quality, cost, safety, and cycle time
• Support process robustness and project management

Requirements

• Bachelor's degree in Engineering, Pharmacy, or Science related field
• English writing, speaking, reading, and listening ability
• 2-5 years of engineering or manufacturing experience in an industrial or cGMP environment

Preferred Qualifications

• Experience managing compliance-related projects
• Familiarity with manufacturing and packaging operations
• Strong knowledge of cGMPs, SOPs, OSHA, FDA, and EMEA regulations
• Proficiency in Microsoft Office and SAP
• Experience in FDA-regulated environments