At Thermo Fisher Scientific team, discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and outstanding contributions. Our dedication to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us!
Location/Division Specific Information
St. Louis, MO / Drug Substance Division - The Drug Substance Division is one of the five divisions that make up the Pharma Services Group. We specialize in both development and commercial drug substance services. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.
How will you make an impact?
A QA Engineer III is a Quality Assurance professional responsible for problem resolution on and off the Quality Control and Manufacturing floor and quality oversight of pharmaceutical production.
Routine Tasks
Coordinate and ensure the successful day-to-day oversite of contract manufactured biologic molecule(s).
Provide quality minded problem resolution to on Manufacturing and Quality Control activities and any critical issues stemming from production and Quality On the Floor.
Supervise and coordinate resolutions of issues and communicate as needed to other QA Engineers or Manager.
Perform review and approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures/Controlled Documents, Technical Transfer Protocols, Deviations, CAPAs, Change Controls, and other Quality Records.
Assisting Product Quality Leads during technology transfer of new products; ensuring development of process adheres to governing regulations based on phase appropriate FDA, EMA and ICH guidelines.
Perform routine quality walk throughs of assigned production and production support areas.
Participate in site inspection readiness activities, inspections, client face to face meetings and core team meetings.
How will you get here?
Education
Bachelor's Degree in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in leu of education requirements. Non-science degrees will be considered with appropriate experience.
Experience
5+ years of proven experience in a GMP Environment. 4-5 years of proven experience within a professional level Quality Assurance, Quality Operations, or Compliance preferred. Ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position. Experience with SAP, TrackWise, and/or Documentum is suggested
Knowledge and Skills
Knowledge of industry standards and cGMP regulations.
Preferred knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals
Ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position
Able to aseptically gown and work in environmental clean rooms, as needed
Proficient knowledge of controlled documentation and data systems
Decision Making and Leadership Skills
Technical knowledge of biopharmaceutical manufacturing is desirable
Abilities
Able to complete job functions under minimum guidance from other Quality personnel. Ability to work 8-hour fixed schedule onsite with possible weekend work or on call coverage. Physical: Regularly required to talk and hear. The employee may be required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today!! http://jobs.thermofisher.com
Disclaimer:
This job description presents the general content and requirements for the performance of this job. The description is not to be construed as an extensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to describe an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully abide by all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Thermo Fisher Scientific is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We strive to build an inclusionary work environment and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or other protected characteristic as outlined by federal, state, or local laws.
