Job Opportunity: Sterility Assurance – Quality
Location: Bloomington, Indiana, United States
Category: Quality
Job Type: Full-time
About Novo Nordisk
For over 100 years, Novo Nordisk has led the way in diabetes care and continues to make a difference in global healthcare. Our Bloomington, Indiana facility is a state-of-the-art site supporting process development, formulation, biomanufacturing, fill/finish, and packaging of clinical and commercial products. Here, talented teams collaborate to deliver high-quality medicines to patients worldwide.
We aspire not only to be the best company in the world, but the best company for the world, driven by innovation, inclusivity, and a patient-first mindset.
What We Offer
Competitive pay with annual performance bonus
14 paid holidays + generous PTO
Health, Dental, and Vision Insurance (effective day one)
8% guaranteed 401(k) contribution + company match
Paid parental leave (14 weeks) & family medical leave (6 weeks)
Free access to Novo Nordisk-marketed medicines
Tuition assistance & career growth opportunities
Life & disability insurance
Employee referral awards
About the Department
The Sterility Assurance team ensures compliance with FDA, regulatory, and internal quality requirements. The group oversees contamination control, aseptic practices, documentation, training, auditing, and continuous improvement of sterility assurance systems—ensuring safe, high-quality products reach patients.
Quality Structure:
Quality Assurance Systems: Deviation & CAPA management, change control, document control, supplier quality, raw material disposition, training, calibration, maintenance, and validation.
Quality Assurance Operations: Oversight of manufacturing, technology transfer, batch record review/approval, floor support, product disposition, and shipping.
Quality & Compliance: Internal/client audits, regulatory inspections, compliance initiatives, and process validation.
Role & Responsibilities
In this role, you will:
Support and track the sterility assurance program across a GMP pharmaceutical manufacturing facility.
Observe, document, and coach aseptic behavior during production and Aseptic Process Simulations (APS/media fills).
Advise on sterility assurance and microbiological protocols/procedures.
Assist leadership with quality system implementation and compliance.
Author, review, and update documents to meet site, global, and regulatory requirements.
Propose and support corrective and preventive actions (CAPAs).
Contribute to the Contamination Control Strategy, ensuring cleanroom compliance and reducing risk of contamination or cross-contamination.
Maintain traceability of observations and escalate to management as needed.
Qualifications
Education: BS in Science (Microbiology preferred).
Experience: Minimum 5+ years in aseptic processing within pharmaceutical/biotech manufacturing.
Strong knowledge of regulatory standards in sterile manufacturing and aseptic processing.
Experience with regulatory inspections and audits.
Physical & Work Requirements
Frequent sitting, standing, walking, computer work, and document review.
Occasional stooping, kneeling, bending, or lifting (up to 50 lbs).
Must meet EHS requirements and gowning certification for aseptic cleanroom access.
Ability to walk/stand for 8–10 hours depending on assigned area.
HVAC-controlled environment.
Diversity & Inclusion
At Novo Nordisk, we believe diverse perspectives drive innovation. We are committed to an inclusive workplace where every employee, regardless of race, ethnicity, gender, sexual orientation, religion, disability, or veteran status, has equal opportunity to thrive.
Application Assistance
If you need accommodation during the application process, please contact us at 1-855-411-5290. This number is for accommodation requests only and cannot provide status updates.
👉 Apply now and join Novo Nordisk to make what matters. Together, we’re life changing.
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