Change Control and Quality Systems Specialist

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 5%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Greenville, NC

RELOCATION ASSISTANCE IS NOT PROVIDED

• Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
• Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

This role focuses on ensuring quality and compliance within regulated environments while supporting continuous improvement and operational excellence across quality systems.

A Day in the Life:

You will support quality systems, manage compliance activities, participate in audits, and contribute to continuous improvement initiatives across regulated environments.

What to expect:

• Manage and support quality systems including CAPA, deviations, and change control
• Ensure compliance with GMP/GxP regulations and ISO standards
• Conduct and support internal and external audits
• Develop and maintain quality documentation such as SOPs
• Analyze data and report on quality metrics
• Collaborate with cross-functional teams to drive improvements

Keys to Success:

Education

Associate or Bachelor degree in Business administration, Data Science, Organizational Psychology, Life Sciences, or a closely related field and a minimum of 4 years of work experience within Quality Assurance and/or Manufacturing

Experience

• Minimum of 4 years of experience within pharmaceutical industry with combination products or medical device experience strongly preferred
• Minimum of 2 years of combined work experience in change management, program/portfolio management, documentation, risk management, or relevant business areas within the pharmaceutical or healthcare industry
• Advanced problem-solving abilities and attention to detail
• Excellent verbal and written communication skills
• Strong interpersonal skills with ability to collaborate across functions and levels
• Proficiency with quality systems software such as TrackWise, KNEAT, Electronic Document Management Systems)
• Proficient in Microsoft Office and data application tools such as Power BI and Tableau
• Ability to work independently and guide cross-functional teams
• Knowledge of risk assessment methodologies and continuous improvement tools
• Project management experience preferred
• Medical device change management experience is a plus
• Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs.