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QC Staff Scientist

Thermo Fisher Scientific

  • Saint Louis, Missouri
  • 9 days ago

    Highlights

    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. In this role, you'll work cross-functionally to lead method development, validation, and transfer activities while providing expert technical guidance on investigations and process improvements.

    Numbers & Facts

    LocationSaint Louis, Missouri
    IndustryAll
    Company Size10,000 employees or more
    Websitehttps://corporate.thermofisher.com/en/home.html

    Description

    Work Schedule

    Standard (Mon-Fri)

    Environmental Conditions

    Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    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.

    DESCRIPTION:
    Join our Quality Control team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff QC Engineer/Scientist, you'll lead quality initiatives and serve as a technical subject matter expert in analytical testing, method validation, and compliance. You'll support continuous improvement while ensuring the highest quality standards for our products that help customers make the world healthier, cleaner, and safer.

    In this role, you'll work cross-functionally to lead method development, validation, and transfer activities while providing expert technical guidance on investigations and process improvements. You'll support team members, communicate with clients, and represent QC in regulatory audits. Your expertise will be essential in maintaining compliance with cGMP requirements and advancing our quality systems through innovative solutions.

    REQUIREMENTS:
    • Bachelor's Degree plus 10 years of experience preferably QC/analytical experience in pharmaceutical/biopharmaceutical industry
    • Extensive expertise in analytical techniques including HPLC, ELISA, cell-based assays, and protein characterization methods
    • Strong understanding of cGMP, FDA regulations, ICH guidelines, and quality systems
    • Proven experience leading method validation, transfer, and stability programs
    • Advanced technical troubleshooting and investigation skills for complex quality issues
    • Experience with quality documentation including SOPs, validation protocols, and regulatory submissions
    • Strong project management abilities to drive multiple concurrent initiatives
    • Excellence in data analysis and statistical evaluation using tools like Minitab/JMP
    • Proficiency with laboratory information management systems and quality tracking systems
    • Strong technical writing and presentation skills
    • Effective interpersonal skills with ability to guide and support others
    • Experience supporting regulatory and client audits
    • Demonstrated expertise in risk assessment and CAPA implementation
    • Proficient in Microsoft Office applications including Excel, PowerPoint, and Word

    Benefits

    We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

    Other

    Relocation assistance is not provided.

    Must be legally authorized to work in the United States now and in the future, without sponsorship.

    Must be able to pass a comprehensive background check, which includes a drug screening.

    About Company

    Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

    All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

    If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

    Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

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