Thermo Fisher Scientific Quality Compliance Specialist III in Saint Louis, Missouri
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
Patheon, Bio Services Division, St. Louis, MO
How will you make an impact?
The Quality Compliance Specialist III/Regulatory Affairs Specialist III is responsible for site inspection readiness, conducting internal audits of Quality systems, facilitation of client audits, and preparing clients for pre-approval inspections. This individual also performs tasks associated with supplier/material qualification and maintenance.
What will you do?
Ensure the site's compliance with FDA, EMA and other cGMP regulations, including client requirements.
Actively participate in site inspection readiness program and execution of regulatory inspections
Facilitate site internal audits including leading, executing, response approval, and tracking remediation activities
Facilitate client audits including preparing, hosting, response development, and tracking closeout activities
Lead supplier/material qualification and maintenance efforts and perform other supplier quality tasks as needed
Participate on and/or lead Change Control Board as needed
How will you get here?
Bachelor's degree in a scientific discipline (Life Sciences, Biotechnology, or equivalent) is required.
At least 5 years of experience in a Quality role in a GXP or other regulated environment required
Previous experience in conducting internal audits of Quality Systems requiredIn-depth knowledge of FDA/EMA regulatory requirements required
Strong understanding of change management within quality systems is required
Previous experience with hosting client audits and regulatory inspections highly preferred
Previous experience with supplier quality functions is highly preferred
Knowledge, Skills, Abilities
Well organized, detailed oriented, and strong time management skills
Strong communication skills and ability to give presentations to site leaders and clients
Ability to interact and collaborate with all levels of the organization, clients, and vendors
Ability to identify and facilitate change
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.
Apply today! http://jobs.thermofisher.com
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.
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.