QA Associate 1 (2nd shift)
Requisition ID: 63480BR
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
St. Louis, MO
How will you make an impact?
Responsible for providing on-the floor QA support to our manufacturing areas. On-the-floor support will be up to 70% of your time. This role will be 2nd shift, with hours of 4p-12:30a typically.
What will you do?
- Responsible for completing training tasks based upon a monitored curriculum.
- Responsible for performing QA approval of suite and equipment changeover between client processes
- Individuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact
- Contribute to continual process improvement by participating in meetings, seminars, and site projects.
- Support internal and external audit requests. Support the drafting of audit responses related to quality and manufacturing
- Perform Quality Assurance on the Floor activities, and ensure the timely and accurate performance of the same from team members. This will include but not be limited to oversight and review of critical operations on the floor; on the floor review of batch records as they are executed; ensuring initiated deviations contain the relevant, SOP-driven information required; development and maintenance of strong working relationships and partnerships with functional area personnel
How will you get here?
- BS/ BA in biology, biochemistry, chemistry or other science related field
- A minimum of two (2) years of cGMP (or other highly regulated industry) experience
- Direct experience of one year with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
- Demonstrated history of building teams and interdepartmental relationships
- Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
- Experience in investigational writing software system is a plus (TrackWise)
- Strong Microsoft Office skills (especially Word and Excel)
- Must be able to read, write, and communicate in English
Knowledge, Skills, Abilities
- cGMP experience and regulatory requirements
- Manufacturing experience is a plus
- Cleanroom experience is a plus
- Tech transfer experience is a plus
- Root cause analysis is a plus
- Analytical and problem solving skills
- Basic math skills
- Strong written and oral communication skills
- Strong attention to detail
- Solid time management and organization skills
- Able to handle difficult situations with tact and diplomacy
- Previous QA on the floor experience is a plus
- Able to lead productive cross functional meetings
- Able to learn and objectively assess technical processes
- Able to work in a rapidly changing climate; reacts well to change
- Able to work in both independent and team based environments
- Able to handle multiple tasks while remaining focused
- Able to understand written/verbal instructions (in English) and execute accurately and independently
- Plan, evaluate and prioritize individual and team assignments without direct supervision
- Proven ability to work with professional discretion on confidential information
- Able to function in a dynamic atmosphere and balance multiple priorities simultaneously
- Able to flex work schedule for investigational purposes or to support meetings
- Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods. Repetitive hand motions.
- Good hearing and capable of specific vision (color, close, and peripheral)
- Able to gown, wear PPE, and work successfully in a clean room environment
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.