Thermo Fisher Scientific QA Associate 3 (Evening/Night Shift) in St. Louis, Missouri

Job Description

QA Associate 3 (Evening/Overnight Shift)

Requisition ID: 74393BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

This is a non-supervisory role, reporting to the Supervisor, QA Operations at the Thermo Fisher Scientific St. Louis site. This is an OFF-SHIFT position to cover evening/overnight activities. The position would be expected to work a rotating schedule that includes weekend work. 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 (SOPs). 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 30% 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.

  • Be 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?

Education

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

Experience

  • A minimum of five (5) years of cGMP (or other highly regulated industry) experience

  • Direct experience of two (2) years 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) 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

Knowledge, Skills, Abilities

Knowledge

  • 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

Skills

  • Analytical, problem solving, and basic math skills

  • Strong written and oral communication skills

Abilities

  • Able to lift < 50 lbs. Walking, sitting, PC focus for long periods of time.

  • Good hearing and vision (color, close, and peripheral)

  • Able to gown and wear PPE

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.