Quality Assurance System Specialist

QA Systems Specialist

Location: Raleigh NC, fully onsite

Monday-Friday 8am-5pm

Salary Range: $76,000-$110,000/year

Position Summary

The QA Systems Specialist is responsible for supporting Quality Assurance systems to ensure compliance with cGMP, FDA, and other applicable regulatory requirements. This role helps maintain inspection readiness by supporting quality systems, change control, audits, quality metrics, and continuous improvement initiatives. Working cross-functionally with Manufacturing, Quality Control, Engineering, Supply Chain, and Regulatory Affairs, the QA Systems Specialist promotes a culture of quality and operational excellence while ensuring products and processes meet established quality standards.

Key Responsibilities

• Support and promote a culture of quality and regulatory compliance across the site.
• Ensure compliance with cGMP, FDA, and applicable regulatory requirements.
• Review quality documentation, including change controls, deviations, investigations, risk assessments, and related quality records.
• Support the administration of the Change Control system, including reviews, approvals, KPI tracking, and documentation.
• Collect, analyze, and report Quality Systems metrics for Management Review meetings and Annual Product Reviews (APRs).
• Provide Quality Assurance oversight and guidance for quality systems activities and change control processes.
• Identify and communicate quality risks, compliance concerns, and regulatory issues to management.
• Support customer audits, regulatory inspections, and inspection readiness activities.
• Participate in internal audits, document findings, and assist with corrective action follow-up.
• Support employee training related to quality systems, cGMP requirements, and data integrity.
• Maintain accurate quality records in accordance with company procedures and data integrity requirements.
• Contribute to continuous improvement initiatives that strengthen quality systems and operational performance.
• Perform additional duties as assigned.

Qualifications

Required

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Minimum of five (5) years of experience in the pharmaceutical, biotechnology, or other cGMP-regulated industry.
• Experience supporting Quality Systems, Quality Assurance, Manufacturing Quality, Validation, or related quality functions.
• Experience participating in regulatory inspections, customer audits, and internal audits.
• Experience with Change Control processes.
• Strong understanding of Quality Systems, Quality Assurance principles, and regulatory compliance.
• Excellent written, verbal, analytical, organizational, and interpersonal communication skills.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook, and PowerPoint).

Preferred

• Working knowledge of cGMP, FDA, and international regulatory requirements.
• Experience with electronic Quality Management Systems (eQMS), including Change Control, Deviations, CAPA, Document Control, and Training.
• Experience supporting validation, capital projects, equipment qualification, or process implementation.
• Knowledge of quality risk management and continuous improvement methodologies.
• Familiarity with data integrity principles and 21 CFR Part 11.
• Experience supporting Annual Product Reviews (APRs), Management Reviews, and quality metrics.
• ASQ, RAPS, or other quality certifications are a plus.

Work Environment

• Position is fully onsite within a pharmaceutical manufacturing environment.
• Work includes office, laboratory, warehouse, and manufacturing areas.
• Must be able to wear required PPE and comply with gowning requirements in controlled manufacturing environments.
• Occasional overtime or schedule flexibility may be required to support audits, inspections, investigations, or business needs.
• Regular collaboration with cross-functional teams is required to support quality and compliance objectives.