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Change Control and Quality Systems Specialist

Thermo Fisher Scientific Inc

Greenville, NC

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JOB DETAILS
SKILLS
Biology, Cancer, Change Control, Change Management, Chemistry, Communication Skills, Continuous Improvement, Control Systems, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Detail Oriented, Document Control, Documentation, External Audit, Food Safety, GMP (Good Manufacturing Practices), GxP, ISO (International Organization for Standardization), ISO 9001, Internal Audit, Interpersonal Skills, Lift/Move 25 Pounds, Maintain Compliance, Medical Equipment, Microsoft Office, Operational Improvement, Physical Demands, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Management, Project/Program Management, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Risk Analysis, Safety Standards, Standard Operating Procedures (SOP), Statistics, Systems Administration/Management, Team Player, Technical Writing, Trend Analysis, Writing Skills
LOCATION
Greenville, NC
POSTED
30+ days ago

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

About the Company

T

Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html