CAPA Program Lead — QA, Cross-Functional Excellence

Thorne; Summerville (SC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Disability insurance

Life insurance

401k plan with employer matching

Gym membership reimbursement

Supplements allowance

Paid time off

Job summary

Thorne in Summerville, SC is seeking a Quality Assurance CAPA Specialist to drive corrective and preventive actions across internal manufacturing, outside contract manufacturers, and suppliers. You will serve as CAPA subject matter expert, coordinating investigations, root cause analysis, and action plans with cross-functional teams.

The role demands strong project management, structured problem solving, and excellent communication to ensure timely, compliant CAPAs and audit readiness.

Qualifications

• Bachelor’s degree or equivalent in a scientific/engineering/quality discipline.
• 5+ years of quality experience, with at least 3 years supporting CAPA activities.
• Experience overseeing CAPAs for external partners (OCMs/suppliers).
• Demonstrated project management and cross-functional collaboration capabilities.

Responsibilities

• Lead CAPA process from initiation to closure, ensuring alignment with cGMP and regulatory expectations.
• Serve as CAPA subject matter expert; guide investigations, root cause analysis, corrective and preventive actions.
• Review CAPAs for effectiveness, maintain audit-ready records, and coordinate with internal/external partners.
• Facilitate CAPA meetings and cross-functional discussions with clear, risk-based actions.

Skills

CAPA management

Root cause analysis

Project management

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in science/engineering/quality

Tools

QA/ CAPA software

Job description

Thorne in Summerville, SC is seeking a Quality Assurance CAPA Specialist to drive corrective and preventive actions across internal manufacturing, outside contract manufacturers, and suppliers. You will serve as CAPA subject matter expert, coordinating investigations, root cause analysis, and action plans with cross-functional teams.

The role demands strong project management, structured problem solving, and excellent communication to ensure timely, compliant CAPAs and audit readiness.