Job Title: QA Associate 4- Batch Closure Specialist
Requisition ID: 108686BR
 
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  *** First Shift: Monday - Friday ***
 
How will you make an impact?
The QA Operations group members are specialists in deviation prevention. This team executes QA on-the-floor activities, batch record review and closure, and approval of deviations and standard operating procedures (SOP). All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.
 
What will you do?             

• Prepare department specific reports and metrics on batch status.
• May spend up to 20% of work hours in manufacturing areas when production is on-going to oversee activities from a quality perspective and answer QA-relevant questions / provide QA input in real-time.
• May participate in QA approval of suite and equipment changeover between client processes
• Serve as QA approver for minor deviations, batch record revisions, SOP revisions, and other required site documentation.
• 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. Utilization of tact and diplomacy with internal and external customers is essential.

• BS/ BA in biology, biochemistry, chemistry or other science related field

• A minimum of four years of cGMP (or other highly regulated industry) experience
• Direct experience of two years with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
• Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements

• Strong computer skills highly preferred (i.e. Excel, Smartsheet, PowerPoint, Word)
• Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
• Demonstrated history of building teams and interdepartmental relationships
• Experience in investigational writing software system is a plus (TrackWise) along with root cause analysis tools utilized in deviation investigations
• Experience in project management with regard to tracking and executing to a deadline.
• Must be able to read, write, and communicate in English
• Physical Demands: lifting < 50 lbs., walking, sitting for longer periods of time, PC focus for long periods of time, good hearing and vision (color, close, and peripheral), able to gown and wear PPEExample 2

 
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.