Thermo Fisher Scientific QA Associate 3 (Product Quality) in St. Louis, Missouri

Job Description

QA Associate 3 (Product Quality)

Requisition ID: 64669BR

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 career goals.

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 Commercial Operations, which is a sub-group within the Quality Unit.

A QA Associate in Product Quality is an experienced QA professional that provides leadership and experience with introduction of new client molecular entities. Performs client quality project management, assisting the client in Quality needs and understanding of Quality guidelines and regulations, ensures commitments and adherence to Quality Agreements. A QA Associate III in Product Quality is a recognized subject matter expert in one or more of the following Quality Assurance areas: cGMP compliance, deviation management, or biopharmaceuticals manufacturing.

This individual is responsible for overseeing quality aspects of one or more clinical and/or commercial products with respect to: master batch record approval, disposition of product, review of process validation protocol, change control approval and ensuring alignment of the programs with respect to phase appropriate requirements and strategies. Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects. Personnel are expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture.

What will you do?

  • Provide guidance and oversight on all aspects of quality to drive clinical and commercial programs towards successful outcomes.

  • Act as Liaison between the Client and sub-groups of Quality Assurance during technology transfer of new products; ensure development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines. Oversight to include work from early phase GMP manufacturing through Commercial.

  • Review and aid in the establishment and maintenance of Client Quality Agreements for assigned program(s).

  • Review and Approve GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures, Process Validation Protocols, Deviations and Change Controls.

  • Contribute to continual process improvement by participating in meetings, seminars, and site projects

How will you get here?

Education

  • Bachelor’s degree in physical science minimally required, preferably in biology, biotechnology, or bioengineering.

Experience

  • 4+ years of experience in QA in a regulated manufacturing environment.

  • Biologics and/or CMO experience is a huge plus.

  • Prior project management experience required.

  • Technical Writing skills required.

  • Prior client interaction in a CMO/pharmaceutical environment or customer service experience is preferred.

  • Must be independent, results oriented and have a depth of experience in regulatory requirements for the manufacturing of API including: facility clean room requirements, batch records, and technical transfer protocol review for clinical and commercial GMP manufacturing.

Knowledge, Skills, Abilities

  • Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.

  • Demonstrated ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position.

  • Demonstrated ability to make key decisions.

  • Team player with the ability to work collaboratively with other functions, gaining their cooperation in dealing with issues of compliance.

  • Strong interpersonal and communications skills, written and oral, and a demonstrated ability to make logical decisions.

  • Rational persuasion, particularly in discussion with manufacturing and with client representatives.

  • Extremely high attention to detail and concern to standards are required.

  • Critical thinking with the ability to read, analyze and interpret technical data.

  • Deductive reasoning with the ability to deal with abstract and concrete variables in situations where only limited standardization exists

  • Must be able to demonstrate ability to work on multiple projects.

  • Good organizational skills and problem-solving abilities.

Physical Demands/Factors:

While performing the duties of this job, the employee is:

  • able to aseptically gown and/or sterile gown as needed

  • able to work within environmental clean rooms

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

  • required 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 sit for extended periods. The employee is occasionally required to stand; walk; 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 65,000 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.

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.