QA Systems Specialist

Kelly Services; North Carolina; On-site; USD 76,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Retirement Plan

Holiday Pay

Transit Benefit

Job summary

The QA Systems Specialist at Kelly Services in Raleigh, NC, is an on-site role supporting cGMP compliant quality systems across change control, audits, metrics, and continuous improvement. You will work cross-functionally with Manufacturing, Quality Control, Engineering, Supply Chain, and Regulatory Affairs to ensure products and processes meet established quality standards.

Responsibilities include reviewing quality documentation, administering the Change Control system, collecting metrics for

Qualifications

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or Engineering).
• Minimum five years in pharma/biotech or cGMP-regulated industry.
• Experience supporting Quality Systems, QA, Manufacturing QA, 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, QA principles, and regulatory compliance.
• Excellent written, verbal, analytical, organizational, and interpersonal communication skills.
• Proficiency with Microsoft Office applications (Word, Excel, Outlook, PowerPoint).

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.

Skills

Communication skills

Analytical thinking

Organizational skills

Interpersonal skills

Technical writing

Education

Bachelor's degree in Chemistry / Biology / Microbiology / Pharmaceutical Sciences / Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Job Description

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employ