Senior QA Specialist: GxP Compliance & Audits

precisionmedicinegroup; Winston-Salem (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Precision Medicine Group is seeking an experienced QA Specialist III to provide on-site, advanced QA support in a GxP laboratory and kitting production environment. You will oversee audits, document control, and release of materials, with a focus on continuous improvement and regulatory compliance.

The role requires strong experience in quality systems, CAPA, and supplier quality management, with a willingness to lead complex audits and training across multiple disciplines.

Qualifications

• Bachelor's degree or equivalent in life sciences.
• 4+ years in a regulated life science environment.
• Experience with internal audits and batch records review.
• Strong documentation and data-management skills.

Responsibilities

• Lead internal and supplier audits; act as lead auditor.
• Review and release of materials and finished products.
• Maintain and improve document control systems and records.
• Provide QA guidance for continuous improvement and training.

Skills

Quality Systems

GxP Compliance

Internal Auditing

Document Control

CAPA

Supplier Quality

Data Analysis

Training

Education

Bachelor's Degree in Life Sciences

Job description

Precision Medicine Group is seeking an experienced QA Specialist III to provide on-site, advanced QA support in a GxP laboratory and kitting production environment. You will oversee audits, document control, and release of materials, with a focus on continuous improvement and regulatory compliance.

The role requires strong experience in quality systems, CAPA, and supplier quality management, with a willingness to lead complex audits and training across multiple disciplines.