Novo Nordisk – Quality Assurance (Sterility Assurance) Role
About the Department
At Novo Nordisk, we have been leading the way in diabetes care for over 100 years. Being part of Novo Nordisk means the opportunity to build a life-changing career while improving the quality of life for millions of people around the world.
Our Catalent, Indiana LLC site in Bloomington, Indiana, is a state-of-the-art facility providing end-to-end services, from process and formulation to clinical and commercial biomanufacturing, drug product fill/finish, and packaging. The Bloomington campus is recognized globally for helping innovators develop, manufacture, and supply high-quality products to patients.
What We Offer
Competitive salary with annual performance bonus
14 paid holidays + generous paid time off
Health, Dental, Vision Insurance (effective Day 1)
401K contribution (8% guaranteed + match option)
Family-focused benefits:
14 weeks paid parental leave
6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition assistance for professional development
Life & Disability Insurance
Employee referral awards
At Novo Nordisk, we provide mentorship, resources, and career growth opportunities so you can realize your potential.
About the Quality Assurance Department
The Quality Assurance (QA) team ensures compliance with FDA regulations, other global regulatory standards, and internal quality systems.
QA Department Focus Areas:
Systems & Documentation: implementation, training, auditing, material disposition
Quality Assurance Systems: deviations, CAPAs, change controls, document control, supplier management, raw material testing/disposition, equipment calibration, preventive maintenance, and validation
QA Operations: oversight of manufacturing, technology transfer, batch record review, on-the-floor support, product disposition, and shipping
Quality & Compliance: internal/client audits, regulatory inspections, compliance initiatives, and process validation
Role Overview
This role provides the opportunity to:
Contribute to projects that directly impact patient lives
Collaborate with cross-functional teams to establish a sterility assurance program for a state-of-the-art pharmaceutical manufacturing facility
Ensure regulatory compliance and risk minimization in aseptic and sterile environments
Key Responsibilities
Develop and implement microbiology and sterility assurance strategies, policies, and procedures
Support leadership in implementing quality systems procedures and ensuring compliance
Act as a core team member for sterility assurance and aseptic operations
Participate in regulatory inspections and internal quality assessments
Contribute to Contamination Control Strategy (CCS) and sterility assurance initiatives to improve clean room controls and reduce contamination risks
Qualifications
8+ years of experience in microbiology and aseptic processing within pharmaceutical/biotech manufacturing
BS degree in Science (Microbiology preferred)
Proven team management and leadership experience
Strong knowledge of industry regulations and sterile manufacturing standards
Experience with regulatory inspections and audits
Physical & Work Requirements
Frequent: sitting, standing, walking, reading, computer work, communication
Occasional: stooping, kneeling, bending, carrying, lifting (up to 50 lbs.)
Must meet EHS responsibilities and gowning certification for aseptic areas
Ability to work in a controlled cleanroom environment for 8–12 hours as required
Diversity & Inclusion
At Novo Nordisk, we aspire not only to be the best company in the world but also the best company for the world. We celebrate diversity in our employees, patients, and communities.
We are an Equal Opportunity Employer – all qualified applicants will be considered without discrimination based on race, ethnicity, gender, identity, orientation, disability, veteran status, or any other protected category.
If you require an accommodation during the application process, please contact us at 1-855-411-5290. (Note: this number is for accommodation requests only.)
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