Quality Specialist, Change Control Management

Experis; Wilson (NC); On-site; USD 83,000 - 90,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Act

Job summary

Experis in Wilson, NC is seeking a Quality Specialist, Change Control Management to join the QA department and lead change control activities across GMP systems. You will review records, assess risks, and ensure timely closure of changes to protect product quality and patient safety.

The role requires a solid QA background in GMP environments, experience with change controls, and familiarity with Veeva Vault or TrackWise. A proactive, detail-oriented professional will thrive here.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 3–5 years QA experience in a GMP environment.
• 2–3 years of experience managing pharmaceutical change controls.
• Familiarity with Veeva Vault, TrackWise or similar platforms.
• Strong knowledge of cGMP, ICH guidelines and data integrity.

Responsibilities

• Lead and coordinate change control activities throughout the change lifecycle.
• Review, assess, and process change control records for GMP systems, facilities, equipment, and documentation.
• Facilitate impact and risk assessments to evaluate effects on product quality, regulatory filings, and patient safety.
• Ensure timely implementation and closure of change controls, escalating issues as needed.
• Support inspection readiness activities related to change management and regulatory compliance.

Skills

Quality Assurance

Change control

GMP knowledge

ICH guidelines

Data integrity

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or related

Tools

Veeva Vault

TrackWise

Job description

Our client, a leader in the pharmaceutical industry, is seeking a Quality Specialist, Change Control Management to join their team. As a Quality Specialist, Change Control Management, you will be part of the Quality Assurance (QA) department supporting cross-functional teams. The ideal candidate will demonstrate strong attention to detail, excellent communication skills, and a proactive approach to continuous improvement, which will align successfully in the organization.

Job Title: Quality Specialist, Change Control Management
Location: Wilson, North Carolina
Pay Range: $60-65

What's the Job?

• Lead and coordinate change control activities throughout the change lifecycle to ensure compliance and efficiency.
• Review, assess, and process change control records for GMP systems, facilities, equipment, and documentation.
• Facilitate impact and risk assessments to evaluate effects on product quality, regulatory filings, and patient safety.
• Ensure timely implementation and closure of change controls, escalating issues as needed.
• Support inspection readiness activities related to change management processes and maintain regulatory compliance.

What's Needed?

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Minimum 3-5 years of Quality Assurance experience in a GMP-regulated environment.
• Experience managing pharmaceutical change controls for at least 2-3 years.
• Familiarity with electronic Quality Management Systems such as Veeva Vault, TrackWise, or similar platforms.
• Strong knowledge of cGMP regulations, ICH guidelines, and data integrity principles.

What's in it for me?

• Opportunity to work in a dynamic and innovative pharmaceutical environment.
• Engage in meaningful projects that impact patient safety and product quality.
• Collaborate with cross-functional teams and develop your professional skills.
• Be part of a company committed to continuous improvement and regulatory excellence.
• Competitive pay rate aligned with industry standards.

Upon Completion Of Waiting Period Consultants Are Eligible For

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

About ManpowerGroup, Parent Company of: Manpower, Experis and Talent Solutions.

Experis® is a global leader in technology services and part of the ManpowerGroup's (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought-after skills and take the next step toward a brighter future. Backed by ManpowerGroup's 75+ years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World's Most Ethical Companies. Learn more at Experis.com.