Thermo Fisher Scientific Staff Quality Engineer in Greenville, North Carolina

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Greenville, NC

How will you make an impact?

Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensures the site can operate without regulatory actions that impede product quality, cause product stoppages, or reduce customer satisfaction.

What will you do?

  • Complies with all job-related safety and other training requirements.

  • Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.

  • Assigned to Processes and projects of high complexity, perform compliance assessments, makes decisions regarding regulatory requirements; ensures adherence to current regulations with little dependence on others.

  • Provides leadership as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.

  • Performs document reviews and makes determinations as to whether work performed meets current procedures and regulatory expectations. Communicates and coordinates with other departments as required to resolve issues and compliance concerns detected during review.

  • Conducts risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

  • Complies with all job-related safety and other training requirements.

  • Routinely interacts with internal and external customers at various organizational levels.

  • Reviews and approves deviations / investigations, master batch records, validation documents, protocols, and other quality related documentation as needed to support clinical and commercial product for sterile operations.

How will you get here?

Education:

  • Bachelor’s degree in Chemistry, Biology, or other technical or physical/life science is required.

Experience:

  • 6-8 years of related experience

  • CDMO experience preferred

Knowledge, Skills, Abilities

  • Understanding of cGMP and how it applies to the work environment.

  • Must be able to write clear, understandable documentation.

  • Ability to follow written and verbal directions with a high level of accuracy.

  • High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy.

  • Must be able to write clear, understandable documentation.

  • High level of verbal communication skills.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.