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Principal Scientist, Qc - Days

4-7 years
Not Disclosed
10 July 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Principal Scientist, QC – Days

Location: Bloomington, Indiana, United States
Company: Novo Nordisk


Job Summary

Novo Nordisk is seeking a Principal Scientist, QC to join its high-performing quality control team in Bloomington, Indiana. This is a full-time on-site role ideal for experienced professionals in cGMP laboratory operations, quality control testing, and root cause analysis. You will lead investigations, support process improvements, and serve as a subject matter expert for analytical chemistry and complex QC equipment. This position offers a dynamic work environment with strong mentorship and career development opportunities at one of the world’s leading healthcare companies.


Key Responsibilities

  • Perform and document cGMP quality control testing independently

  • Operate basic and moderately complex lab equipment

  • Lead and document investigations using TrackWise, including CAPAs

  • Author and review SOPs, reports, and deviation documentation

  • Oversee data integrity through LIMS and ensure accurate reporting

  • Train staff on analytical techniques and SOP adherence

  • Actively contribute to process improvement and risk mitigation initiatives

  • Present findings at the Deviation Review Board and lead trend analysis

  • Act as SME on QC methods and technical issues across departments


Required Skills & Qualifications

  • Bachelor’s degree with 7–9 years of experience (4+ years in GMP environment)

  • OR Master’s degree with 4–6 years of experience in GMP or regulated industry

  • OR PhD with 0–4 years of experience (GMP preferred)

  • Strong background in analytical chemistry and lab equipment

  • Knowledge of cGMP, GLP, GDP, SOPs, and aseptic techniques

  • Skilled in investigations, data integrity, CAPA, and laboratory operations

  • Excellent communication, multi-tasking, and documentation skills

  • Experience with cleanroom procedures, LIMS, and TrackWise preferred


Perks & Benefits

  • Competitive base salary and annual performance bonus

  • Health, dental, and vision insurance from day one

  • Guaranteed 8% 401K contribution + optional individual match

  • 14 paid holidays and generous PTO

  • 14 weeks of paid parental leave and 6 weeks of family medical leave

  • Free access to Novo Nordisk-marketed medications

  • Tuition assistance, life and disability insurance

  • Employee referral awards and wellness initiatives


Company Description

Novo Nordisk is a global leader in diabetes care and chronic disease treatment. The Bloomington, Indiana site plays a key role in clinical and commercial biomanufacturing, with a focus on fill/finish, packaging, and integrated product development. Novo Nordisk promotes a culture of inclusion, scientific innovation, and life-changing impact for patients worldwide.


Work Mode: On-site – Bloomington, Indiana, USA


Call-to-Action

Are you a seasoned QC professional ready to drive scientific excellence at a global healthcare leader? Apply now and be part of a mission that’s changing lives.

Explore Careers at Novo Nordisk