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.
This is a non-supervisory role, reporting to the Supervisor of QA Operations, which is a sub-group within the Quality Unit.
A QA Engineer III is a QA professional that provides leadership and experience with introduction of new client molecular entities. A QA Engineer III is a recognized subject matter expert in one or more of the following Quality Assurance areas: cGMP compliance, GLP, biopharmaceuticals manufacturing, and/or regulatory affairs, as warranted to each specific program.
A QA Engineer III is responsible for problem resolution on and off the manufacturing floor and quality oversight of Production Support Areas (QC, Warehouse, etc.). They are also responsible for, but not limited to, batch record review, change control approval and ensuring alignment of the Clinical and Commercial Ops program with respect to phase appropriate requirements and strategies. Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects. Personnel are expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency.
Location/Division Specific Information
St. Louis, MO | Pharma Services Group – Biologics
How will you make an impact?
Provides leadership by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
What will you do?
Oversees and ensures the successful day-to-day oversite of contract manufactured biologic molecule(s).
- Responsible for completing training tasks based upon a monitored curriculum.
- Provide quality minded problem resolution to on the floor manufacturing activities and any escalations stemming from Quality Techs.
- Provide guidance and approval from a quality perspective on deviations.
- Assisting Product Quality Leads during technology transfer of new products; ensuring development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines. Oversight to include work from Process Development to Process Validation
- Monitors for quality related issues and coordinates resolutions.
- Review and Approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures, Technical Transfer Protocols, Deviations and Change Controls.
- Contribute to continual process improvement by participating in meetings, seminars, and site projects
- Participates in Client audits. Coordinates with Program Management on client communications. Attend customer Face to Face meetings as needed.
How will you get here?
- High school diploma / GED is required.
- Bachelor's Degree is preferred in biology, biochemistry, chemistry or other science related field or equivalent experience.
- Non-science degrees will be considered with appropriate industry experience.
- 8+ years within a GMP Environment or relevant regulated environment is preferred.
- 5+ years of experience in Quality Assurance and/or Validation, or equivalent pharmaceutical industry experience is preferred.
- Must have experience as an independent, results oriented individual contributor.
- Experience in regulatory requirements for manufacturing of API including, facility clean room requirements, batch record and technical transfer protocol review for clinical and commercial GMP manufacturing, as well as, validation experience in one of the following: process, method, equipment, or analytical instruments is preferred.
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.
- Working knowledge of controlled documentation and data systems.
- Able to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- Technical Writing Skills
- Decision Making Skills
- Technical knowledge of biopharmaceutical manufacturing is desirable.
- Demonstrated ability to make key decisions.
- Demonstrated ability to work on multiple assignments effectively.
- Excellent organizational skills and problem-solving abilities.
- Able to aseptically gown and work in environmental clean rooms, as needed.
- Team player with the ability to work collaboratively with other functions, gaining their cooperation in dealing with issues of compliance
- Able to execute job functions limited guidance/ oversight and serve as an escalation point and/or mentor for lower band QA Engineers and QA Technicians.
- Ability to work 8-hour fixed schedule with occasional weekend work or on call coverage.
- Physical: Regularly required to talk and hear. The employee frequently is 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. Occasional heavy lifting or moving (~40 lbs).
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.
To Apply, please click the following link: https://thermofisher.contacthr.com/82218324
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