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    Scientist, Qc

    Novo Nordisk
    3-5 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

    Quality Control Scientist

    Location:

    Bloomington, United States

    Job Category:

    Research

    About the Department

    At Novo Nordisk, we strive to make a difference. For over 100 years, we have been at the forefront of diabetes care. Being part of Novo Nordisk provides employees with an opportunity to build life-changing careers while contributing to the quality of life improvement for millions of people worldwide.

    As part of Novo Nordisk, Catalent, Indiana LLC., our Bloomington, Indiana site is a state-of-the-art facility providing an integrated model for process and formulation development, clinical and commercial biomanufacturing, and drug product fill/finish and packaging. Our talented teams work with innovators to develop, manufacture, and supply products for patients around the globe.

    What We Offer You:

    • Competitive salary with an annual performance bonus

    • 14 paid holidays and generous paid time off (PTO)

    • Health, dental, and vision insurance effective day one

    • Guaranteed 8% 401K contribution with additional company match option

    • Family-focused benefits, including 14 weeks of paid parental leave and 6 weeks of paid family medical leave

    • Free access to Novo Nordisk-marketed pharmaceutical products

    • Tuition assistance

    • Life & disability insurance

    • Employee referral awards

    At Novo Nordisk, we offer resources, mentorship, and opportunities to grow and develop your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

    About the Quality Control (QC) Team

    The Quality Control (QC) team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency of products produced by our facility. The QC team consists of several specialized groups:

    Microbiology:

    • Conducts microbial enumeration testing, endotoxin testing, data analysis, and reporting.

    Environmental Monitoring:

    • Ensures microbial control effectiveness by performing routine and investigational sampling of the manufacturing environment.

    Stability:

    • Performs analytical testing and ICH stability studies to determine product stability.

    Release & In-Process Testing:

    • Conducts analytical testing to support the manufacturing and release of bulk drug substances and drug products.

    Method Validation:

    • Supports the validation of analytical methods essential for Stability and Release & In-Process testing teams.

    Sample Management:

    • Oversees sample management, stability chambers, and laboratory critical reagents.

    Raw Materials:

    • Conducts material inspection, sampling, and testing for raw materials and components.

    Additional Functions:

    • Includes technical data review, training, instrument maintenance, lead investigation, and LIMS administration to support the entire QC department.

    The Position

    This role requires a variety of scientific, analytical, and operational skills necessary for a biotech company. The QC Scientist will perform routine testing of process samples, raw materials, and finished products while adhering to cGMP guidelines. Responsibilities also include data interpretation, documentation, and continuous improvement initiatives.

    Key Relationships:

    • Reports to: Quality Control Supervisor

    Essential Responsibilities:

    • Independently execute and document cGMP Quality Control testing.

    • Operate and maintain basic to moderately complex QC laboratory equipment.

    • Assist in authoring SOPs and technical reports.

    • Prioritize and schedule tasks to meet deadlines.

    • Support continuous improvement initiatives.

    • Train team members in specific analytical techniques.

    • Perform self-review of analytical data for accuracy and consistency.

    • Enter data into Laboratory Information Management System (LIMS).

    • Conduct routine laboratory housekeeping in compliance with 5S standards.

    • Initiate and assist in TrackWise records.

    • Complete routine and preventive maintenance on equipment.

    • Participate in team meetings and training sessions.

    • Perform other duties as assigned.

    Investigation Team Responsibilities:

    • Coordinate immediate corrective actions with QA and management for non-conformances.

    • Conduct investigative interviews with subject matter experts and involved employees.

    • Utilize problem-solving techniques to determine root causes and CAPA actions.

    • Draft investigation reports with minimal guidance.

    • Identify and analyze trends from investigations.

    • Support data collection for KPI reports, client reviews, and quality meetings.

    • Facilitate root cause analysis meetings.

    • Manage trend CAPAs and assess their effectiveness.

    Physical Requirements:

    • Frequent sitting, standing, walking, reading, and using a computer.

    • Occasional stooping, kneeling, crouching, bending, and lifting (up to 50 lbs).

    • Must follow EHS safety responsibilities.

    • Lab work involves exposure to skin irritants, lung irritants, sharp instruments, and hazardous waste. Proper safety procedures will be followed.

    Qualifications:

    Education & Experience:

    • Bachelor’s degree in a science-related field with 3-5 years of experience (1-year GMP experience required).

    • Master’s degree in a science-related field with 0-2 years of experience (1-year GMP experience preferred).

    • PhD in a science-related field with 0-2 years of experience (GMP experience preferred).

    Technical Skills:

    • General laboratory equipment experience (e.g., micropipettes).

    • Strong understanding of analytical chemistry and lab equipment maintenance.

    • Knowledge of cGMP, GDP, GLP, and SOPs.

    Behavioral Competencies:

    • Strong problem-solving and risk mitigation skills.

    • Ability to multi-task in a fast-paced environment.

    • Excellent attention to detail and time management skills.

    • Strong written and verbal communication skills.

    • Positive attitude with the ability to work independently and in teams.

    Equal Opportunity Employer

    Novo Nordisk is an equal opportunity employer committed to diversity, equity, and inclusion. We ensure equal employment opportunities regardless of race, ethnicity, gender, disability, veteran status, or any other protected characteristic.

    Application & Accommodation Requests:

    If you need special assistance or an accommodation to apply, please call 1-855-411-5290 (for accommodation requests only).

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    Canada |

    Ontario :

    Richmond Hill | Renfrew | North York | Uxbridge | Mississauga | Australia |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    Estonia :

    Tartu | Estonia |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Athens | Koropi |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

    Netanya | Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv |

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Saitama | Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    New Zealand :

    New Zealand |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Slovakia | Leinster | Castlebar | Remote, USA | Manipal | Belgium | Remote - Africa | Bishop | Minnesota | Springville | Zaragoza | Nairobi | Hungary | Faridabad | Ireland | French | McFarland | Xzagreb | Medan | Melbourne | Lenexa | Remote - South America (Latin Americal) | Bountiful | Blue Bell | Remote - Europe | Lousiana | Remote | Hammond | Remote - Middle East | Riga | Thailand | Switzerland | Texas | Green Way | Tulsa | Victoria |

    Bucharest :

    Bucharest |

    Makkah :

    Rabigh | Khulais | Riyadh | Najran | Jeddah | King Abdullah Economic City |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |