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Thermo Fisher Scientific QA Senior Associate in Saint Louis, Missouri

QA Associate 3 (Senior) - Day Shift / Rotating Schedule

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: This is a non-supervisory role, reporting to the Supervisor of QA Operations at the Thermo Fisher St. Louis site. This is an 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.

Impact: The QA Operations group members are specialists in deviation prevention. This team executes QA on-the-floor activities, 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 and batch record review in real-time.

  • Execute quality review and closure of manufacturing batch records - facilitating corrections.

  • 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. Similar equivalent experience will be considered.

  • A minimum of two (2) years of cGMP (or other highly regulated industry) experience

  • Direct experience of two years (1) with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred

  • 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

Knowledge, Skills, Abilities

  • 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.