Bloomington, United States
Research
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.
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.
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:
Conducts microbial enumeration testing, endotoxin testing, data analysis, and reporting.
Ensures microbial control effectiveness by performing routine and investigational sampling of the manufacturing environment.
Performs analytical testing and ICH stability studies to determine product stability.
Conducts analytical testing to support the manufacturing and release of bulk drug substances and drug products.
Supports the validation of analytical methods essential for Stability and Release & In-Process testing teams.
Oversees sample management, stability chambers, and laboratory critical reagents.
Conducts material inspection, sampling, and testing for raw materials and components.
Includes technical data review, training, instrument maintenance, lead investigation, and LIMS administration to support the entire QC department.
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.
Reports to: Quality Control Supervisor
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.
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.
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.
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).
General laboratory equipment experience (e.g., micropipettes).
Strong understanding of analytical chemistry and lab equipment maintenance.
Knowledge of cGMP, GDP, GLP, and SOPs.
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.
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.
If you need special assistance or an accommodation to apply, please call 1-855-411-5290 (for accommodation requests only).
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
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Tallinn |Hà Nội :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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Warsaw |
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