Thermo Fisher Scientific QA Senior Technician 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 goals.
Location/Division Specific Information
St. Louis, MO
How will you make an impact?
This is a non-supervisory role, reporting to the Supervisor of QA Operations at the Thermo Fisher St. Louis site. This is a day shift position to cover production activities. This position would be expected to work a rotating schedule that includes weekend work . The St. Louis site is part of the Biologics division.
The QA Operations group members are specialists in deviation prevention. This team executes QA on-the-floor activities, executed batch record review, 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?
Spend up to 70% 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.
Responsible for performing 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.
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 (1) with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
Knowledge, Skills, Abilities
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
Strong Microsoft Office skills (especially Word and Excel)
Must be able to read, write, and communicate in English
cGMP experience and regulatory requirements
Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements
Tech transfer experience is a plus
Analytical, problem solving, and basic math skills
Strong written and oral communication skills
Physical Demands: lifting
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.