Quality Systems Lead — Pharma Compliance (Onsite)

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

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