QA Systems Specialist

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. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.