Thermo Fisher Scientific Staff QA Engineer 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?
This role is responsible for oversight of the Quality Risk Management program and is a primary contact for Regulatory Affairs. This includes site inspection readiness, conducting internal audits of Quality systems, facilitation of client audits, regulatory assessment of the Critical Change Control process, site regulatory filing management/oversight, and a regulatory point of contact for clients. This role is also responsible providing guidance to risk assessment teams and authors as required. This individual ensures compliance with FDA, EMA and other cGMP regulations, including client requirements.
What will you do?
Ensure the site's compliance with FDA, EMA and other cGMP regulations, including client requirements.
Oversee the site's Quality Risk Management system and provide support to the site for quality risk assessments, collaborating with functional areas to identify, assess and mitigate risk.
Lead an effective quality risk management program as it relates to clinical and commercial programs and the manufacturing facility.
Actively participate in site inspection readiness program and execution of regulatory inspections
Lead site internal audits including executing, response approval, and tracking remediation activities
Facilitate client audits including preparing, hosting, response development, and tracking closeout activities
Participate on and/or lead Change Control Board as needed
Provide interpretation and guidance to site personnel with respect to current regulations that apply directly or indirectly to approved drug products.
Provide knowledge of current cGMP requirements and trends to ensure that the appropriate technical support on all quality/compliance related matters is provided to the site.
Maintain the site's regulatory filings
Field client regulatory requests and assist with client regulatory filings as required
Train and mentor junior staff members
How will you get here? Education
Bachelor's degree in a scientific discipline (Life Sciences, Biotechnology, or equivalent) is required.
At least 7 years of experience in a Quality role in a cGMP environment required
At least 2 years of experience as a Quality Risk Management lead
At least 2 years of experience in conducting internal audits of Quality Systems required
In-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
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 65,000 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.