QC Compliance Specialist - CAPA & Deviation Lead

CSL; Holly Springs (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

CSL is seeking a QC professional to support core quality systems including deviation investigations, CAPA management, incident handling, controlled document writing and change control. The role includes ownership of QC investigations, use of SAP, LIMS, Data Historian, and Trackwise systems, and coordination of work orders while ensuring regulatory compliance.

The candidate will participate in lean lab operations, maintain KPIs, and contribute to continuous improvement initiatives in a GMP

Qualifications

• Bachelor’s degree and 2+ years’ experience or equivalent.

Responsibilities

• Leads deviation investigations to identify root cause and implement CAPAs to prevent recurrence.
• Own CAPAs as appropriate and use standard RCA tools.
• Investigation/Deviation system ownership, tracking statuses, leading investigations teams.
• Support QC with assigned business process systems (SAP, LIMS, Data Historian, Trackwise).
• Maintain documentation, metrics and KPIs for leadership review.

Skills

Quality systems

CAPA

Investigation

Root cause analysis

Written communication

Education

Bachelor’s degree

Tools

SAP

LIMS

Data Historian

Trackwise

Job description

CSL is seeking a QC professional to support core quality systems including deviation investigations, CAPA management, incident handling, controlled document writing and change control. The role includes ownership of QC investigations, use of SAP, LIMS, Data Historian, and Trackwise systems, and coordination of work orders while ensuring regulatory compliance.

The candidate will participate in lean lab operations, maintain KPIs, and contribute to continuous improvement initiatives in a GMP