Senior Quality Assurance & Compliance Auditor (cGMP)

Keystone Distinction Group; Lancaster (SC); On-site; USD 90,000 - 120,000; Full time

Job summary

Keystone Distinction Group seeks a QA Inspector to build and sustain a robust Internal Compliance program. You will perform internal and external audits, manage vendor qualifications, and drive corrective actions in a regulated environment.

Responsibilities include audit planning, risk assessment, and training across departments to meet Quality Assurance expectations and regulatory inspection readiness. Travel up to 20–30% may be required.

Qualifications

• Minimum 5 years QA auditing in a cGMP environment.
• Experience with external vendor/supplier audits in FDA-regulated industries.
• Knowledge of 21 CFR Part 210, 211, 507 and 21 CFR 111 dietary supplement regs.

Responsibilities

• Plan, schedule, and conduct internal and external audits.
• Audit suppliers and manage vendor qualification.
• Manage supplier corrective action requests and documents.
• Assess risk of findings and track corrective actions.
• Develop performance tracking and reporting for compliance.
• Train internal departments on Quality and Compliance expectations.
• Support regulatory inspections readiness.

Skills

Quality Assurance auditing

cGMP knowledge

FDA regulations

ASQ CQA (preferred)

MS Office proficiency

Education

B.A. or B.S. in Science/Technical field

Tools

MS Office

Job description

Keystone Distinction Group seeks a QA Inspector to build and sustain a robust Internal Compliance program. You will perform internal and external audits, manage vendor qualifications, and drive corrective actions in a regulated environment.

Responsibilities include audit planning, risk assessment, and training across departments to meet Quality Assurance expectations and regulatory inspection readiness. Travel up to 20–30% may be required.