Senior QA Auditor & Compliance Lead (GxP)

Precision Medicine Group; Winston-Salem (NC); On-site; USD 92,000 - 137,000; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group seeks a Quality Assurance Specialist III to provide on-site, advanced QA support in a GxP environment in Winston-Salem, NC. You will manage audits, CAPA, document control, and material release, ensuring compliance and timely issue resolution.

Responsibilities include leading audits, monitoring quality metrics, and guiding junior staff, with extended hours as needed for business demands and regulatory readiness.

Qualifications

• Bachelor’s Degree or equivalent combination of education and experience.
• 4 years of related experience in a life science, regulated environment.
• Experience independently conducting internal audits, document reviews, batch release, and inspections.
• Knowledge of root cause analysis tools and durable corrective/preventive actions.
• Must become an active member of Society for Quality Assurance (SQA) and company supports membership fees.

Responsibilities

• Assist in maintaining GxP quality systems and document events with timely closure/resolution.
• Lead internal audits, supplier audits, and desk audits; act as lead auditor.
• Analyze monthly metrics and present quality data to management with actionable insights.
• Respond to supplier look-back notifications and determine disposition of material.
• Support equipment calibration programs for timely maintenance and accuracy.
• Provide guidance to junior QA specialists and support training across disciplines.
• Lead client visits/audits and represent QA in project kick-offs and customer complaints.
• Create and conduct site-wide training for multiple disciplines.

Skills

QA

Auditing

GxP

Document control

CAPA

Label control

Data analysis

Training

Communication

Project collaboration

Education

Bachelor’s Degree or equivalent combination of education and experience

Job description

Precision Medicine Group seeks a Quality Assurance Specialist III to provide on-site, advanced QA support in a GxP environment in Winston-Salem, NC. You will manage audits, CAPA, document control, and material release, ensuring compliance and timely issue resolution.

Responsibilities include leading audits, monitoring quality metrics, and guiding junior staff, with extended hours as needed for business demands and regulatory readiness.