Change Control and Quality Systems Specialist

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.

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

• Advanced degree plus 1 years of experience, or bachelor’s degree plus 3 years of experience in quality assurance/quality control.

• MUST HAVE MEDICAL DEVICE EXPERIENCE

Experience

• Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology, Validation or related technical field

• Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements

• Experience with quality management systems, CAPA processes, deviation management, and change control

• Proficiency in statistical analysis, data trending, and quality metrics reporting

• Strong technical writing skills for authoring SOPs, change control, and other quality documentation

• Experience conducting and hosting internal/external audits and regulatory inspections

• 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 (TrackWise, KNEAT, Document Control Systems) and Microsoft Office Suite

• 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

Competencies

Innovative

Customer centric

Self-motivated

Accountable

Effective Communication

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.