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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.