Operations Compliance Specialist - CSS

The Operations Compliance Specialist provides technical and regulatory expertise to the investigation and deviation management process to ensure patient safety, regulatory compliance, and inspection readiness. The role involves participating in Rapid Response Team fact gathering, writing Investigation reports, proposing CAPAs, and deploying industry-standard lean and six sigma tools.

Requirements

• Participate in and facilitate Rapid Response Team fact gathering
• Write Investigation reports
• Propose CAPAs
• Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events
• Facilitate cross-functional problem-solving event
• Author SOPs and work instructions
• Review investigation documentation for OOS, OOT or atypical results, as well as deviations from regulations, corporate policy or site procedures
• Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner

Benefits

• Competitive medical benefits
• 401K
• 152 hours PTO
• 8 Paid Holidays