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Thermo Fisher Scientific QA Tech II, Manufacturing in St. Louis, Missouri

Shift: Sunday-Wednesday, starting at 06:00am and ending at 4:30pm (10-hour)

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

St. Louis, MO / Drug Substance Division - The Drug Substance Division is one of the five divisions that make up the Pharma Services Group. We specialize in both small and large molecule development and commercial drug substance services. This allows us to serve the needs of Small/Emerging, Mid-Sized and Large Pharma sectors globally.

Discover Impactful Work:

The QA Operations group members are specialists in deviation prevention. This team implements 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 substances for clinical and commercial clients.

A day in the Life:

  • Spend up to 70 % of work hours in manufacturing areas when production is ongoing to coordinate activities from a quality perspective and answer QA-relevant questions / provide QA input and batch record review in real-time.

  • Implement 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.

  • Ability to obtain consensus and collaboration 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.

Keys to Success:

Education

  • High school diploma or equivalent required.

Experience

  • 1+ years of experience working in a biopharmaceutical or laboratory environment or quality role.

  • Experience in manufacturing and/or GMP environment preferred.

Knowledge, Skills, Abilities

  • Knowledge of cGMP practices, aseptic techniques, or chemical concepts are seenas a plus.

  • Math skills.

  • MS Office.

  • Prioritization, multiasking and detail oriented.

  • Ability to lift <50 pounds, walking sitting, and PC focus for long periods of time.

  • Strong communication (written and verbal)

  • Able to work in an environment of change including office and ISO cleanroom.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.

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