Senior QA Specialist – GxP, Audits & Release

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

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a QA Specialist III to provide on-site, advanced QA support in a regulated laboratory setting focusing on GxP compliance. You will manage inspection, release, and documentation activities for raw materials, in-process materials, and finished products.

The role requires leading audits, CAPA, and continuous improvement initiatives while guiding junior staff. Strong English communication and regulatory knowledge are essential for success in this environment.

Qualifications

• Bachelor’s Degree or equivalent combination of education and experience.
• 4 years of related experience in a life science, regulated environment.
• Experience working in a Quality Department/Life Sciences-regulated environment.
• Knowledge of root cause analysis tools and corrective/preventive actions.
• Active member of Society for Quality Assurance (SQA) preferred; membership fees supported by the company.
• Strong communication and documentation skills; ability to work independently.

Responsibilities

• Lead internal audits, supplier audits, and act as lead auditor.
• Manage the document and record control system.
• QA review of customer specifications to meet contractual requirements.
• Generate and maintain Certificates of Analysis for finished products and for resale.
• Provide training and guidance to junior QA specialists; support continuous improvement initiatives.
• Support regulatory audits, client visits, and project kick-offs as needed.
• Develop and distribute controlled quality system documentation.

Skills

Quality Assurance

Auditing

Root Cause Analysis

Documentation Review

Regulatory Knowledge

English Communication

Education

Bachelor’s Degree or equivalent

Tools

Microsoft Office

Job description

Precision Medicine Group is seeking a QA Specialist III to provide on-site, advanced QA support in a regulated laboratory setting focusing on GxP compliance. You will manage inspection, release, and documentation activities for raw materials, in-process materials, and finished products.

The role requires leading audits, CAPA, and continuous improvement initiatives while guiding junior staff. Strong English communication and regulatory knowledge are essential for success in this environment.