Thermo Fisher Scientific QA Associate 2 in St. Louis, Missouri

Job Description

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 Manager of QA Validation, which is a sub-group within the Quality Assurance Department. This role will assist functional departments with Quality needs and understanding of Quality procedures and Regulations. A QA Associate is a recognized subject matter expert in one or more of the following validation focused areas: equipment, instruments, facilities, utilities, cleaning, sterilization, computer systems, process, method. This individual is responsible for overseeing quality aspects for documentation and processes related to these areas. Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects.

What will you do?

  • Review and approve documentation, including validation periodic reviews, plans, protocols, summary reports, and all other validation related documentation.

  • Advise functional departments on Quality procedures and Regulations to ensure compliant validation documentation.

  • Complete change management assessments for validated equipment, systems, and processes.

How will you get here?

Education

  • Bachelor’s Degree in Engineering, Life Sciences or Computer Science.

Experience

  • 2-5 years of experience in Quality Assurance and/or Validation, or equivalent pharmaceutical industry experience.

  • Direct experience in two or more of the following areas: Process Validation; Method Validation; Validation of computerized systems, software, automation, analytical instruments, utilities, manufacturing equipment, cleaning, sterilization, or general equipment validation.

Knowledge, Skills, Abilities

  • Exposure and knowledge of industry standards and cGMP regulations.

  • Demonstrated ability to work on multiple assignments effectively.

  • Excellent organizational skills and problem solving abilities.

  • Technical Writing Skills

  • Able to aseptically gown and work in environmental clean rooms, as needed.

  • Able to function in a rapidly changing environment and balance multiple priorities simultaneously.

  • Able to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

  • Regularly required to talk and hear. The employee frequently is required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

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.