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    Senior Scientist, Qc

    Novo Nordisk
    5-7 years
    Not Disclosed
    Bloomington United States
    10 Feb. 13, 2025
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Quality Control (QC) Scientist

    Location: Bloomington, United States

    Department: Research

    Job Category: Research

    About the Department:
    At Novo Nordisk, we are dedicated to making a difference. For over 100 years, we have led in diabetes care and continue to help improve the lives of millions globally. Our Bloomington campus, a part of Novo Nordisk's Catalent, Indiana LLC, is a state-of-the-art facility specializing in biomanufacturing, formulation, clinical and commercial production, and drug product packaging. This integrated facility works with talented teams to deliver high-quality products to patients worldwide.

    What We Offer:

    • Competitive pay with annual performance bonuses
    • Generous paid time off including 14 paid holidays
    • Health, Dental, and Vision Insurance (effective from day one)
    • Guaranteed 8% 401K contribution with additional company match
    • Family-focused benefits (14 weeks paid parental leave, 6 weeks paid family medical leave)
    • Free access to Novo Nordisk-marketed pharmaceutical products
    • Tuition Assistance and Life & Disability Insurance
    • Employee Referral Awards

    Position Overview:
    The QC team ensures the safety, quality, identity, purity, and potency of products produced at the facility. The position involves routine testing of process samples, raw materials, finished products, and stability samples. The individual will support preventive maintenance, basic lab activities, and continuous process improvement while adhering to GMP standards.

    Key Responsibilities:

    1. Quality Control Testing:

      • Independently execute cGMP QC testing and document results properly.
      • Operate basic to moderately complex QC equipment.
      • Assist in authoring technical documents like SOPs and reports.
      • Coordinate with Supervisor to schedule and prioritize activities to meet deadlines.
      • Support training in analytical techniques.
      • Perform self-reviews of analytical data for accuracy.
      • Use LIMS (Laboratory Information Management System) to enter and review data.
      • Maintain laboratory cleanliness in adherence to 5S standards.
      • Perform routine and preventive maintenance on equipment.

    2. Investigation Team:

      • Ensure timely completion of investigations related to non-conformances through Trackwise.
      • Collaborate with QA and management to investigate reported problems and assess their impact.
      • Conduct investigations, including root cause analysis and developing CAPA actions.
      • Write and close out investigation reports, identifying trends for continuous improvement.
      • Present major deviations to the Deviation Review Board (DRB).
      • Track and follow up on CAPAs and their effectiveness.

    3. Physical Requirements:

      • Frequent sitting, standing, walking, and use of computer monitor.
      • Occasional stooping, kneeling, crouching, and lifting (up to 50 pounds).
      • Work in a controlled lab environment with potential exposure to irritants, sharp instruments, and hazardous materials.
      • Safety protocols including clean room gowning must be followed.

    Qualifications:

    • Education and Experience:
      • Bachelor’s degree in science with 5-7 years of experience, including at least 2 years in a GMP environment, OR
      • Master’s degree in science with 2-4 years of experience in GMP, OR
      • PhD in science with 0-2 years of experience in GMP.
      • Experience in raw material testing is required.
    • Preferred:
      • Strong understanding of analytical chemistry and lab equipment.
      • Experience with clean room procedures, aseptic techniques, and GMP practices.
      • Familiarity with quality control systems like SOPs, GDP, and GLP.
      • Experience with troubleshooting QC equipment.

    Technical Skills:

    • Proficiency in laboratory techniques including micropipettes, and QC testing.
    • Expertise in conducting investigations and deviations, determining root causes, and implementing corrective actions.
    • Serve as a technical consultant for internal and external customers.
    • Mentoring and serving as a technical resource within the QC team.

    Behavioral Skills:

    • Excellent communication skills in English, both written and verbal.
    • Ability to manage time effectively and independently.
    • Adaptability, problem-solving skills, and ability to multi-task in a fast-paced environment.
    • Positive attitude and team-oriented with the ability to work with diverse individuals and manage high-pressure tasks.
    • Strong organizational skills with attention to detail.

    Equal Opportunity Employer:
    Novo Nordisk is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law.

    Special Assistance:
    If you require special assistance or an accommodation to apply, please contact us at 1-855-411-5290. This contact is only for accommodation requests, and cannot be used to inquire about the status of applications.

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