Associate Representative, Quality Assurance (3rd Shift – 11 PM to 7:30 AM)
Location: Bloomington, Indiana, USA
Work Mode: On-site | Shift: Sunday–Thursday, 3rd Shift
Job Summary:
Novo Nordisk is hiring a QA Associate Representative for its 3rd shift operations at the Bloomington, IN biomanufacturing site. This hands-on role supports GMP operations, batch review, supplier quality oversight, deviation/CAPA management, and audit readiness. Ideal for professionals looking to start or grow their quality career in a high-impact, fast-paced, regulated pharmaceutical environment.
Key Responsibilities:
Provide QA floor oversight during GMP manufacturing, including AQL visual inspections and room releases.
Support supplier qualification, audit prep, complaint investigations, and CAPA tracking.
Execute and support quality documentation processes including SOP edits and MBR reviews.
Participate in internal, client, and regulatory audits (front and back room responsibilities).
Support issuance and review of controlled documents (Batch Production Records, labels, forms).
Monitor warehouse materials and assess damaged product integrity.
Contribute to deviation handling, risk assessment, and change control activities.
Drive continuous improvement and operational excellence within QA systems.
Required Skills & Qualifications:
Education: Bachelor’s degree preferred
Experience: 0–2 years (minimum 1 year in GxP or regulated industry preferred)
Technical Competencies:
Knowledge of CGMPs and pharmaceutical quality systems
Proficiency in MS Office (Excel, Word); exposure to TrackWise® or ComplianceWire® a plus
Ability to edit SOPs and technical reports under guidance
Understanding of deviation management and change control
Intermediate understanding of pharma manufacturing/lab processes
Behavioral Competencies:
Strong communication, organizational, and decision-making skills
Attention to detail under pressure with ability to manage multiple tasks
Team-oriented with leadership potential; able to work independently
Willingness to operate in cleanroom and lifting environments (up to 50 lbs)
Perks & Benefits:
Competitive base salary + annual performance bonus
14 paid holidays and generous time-off policy
Day-one health benefits: Medical, dental, vision insurance
8% guaranteed 401(k) contribution + additional employer match
Paid leave: 14 weeks parental and 6 weeks family medical leave
Tuition reimbursement and life/disability insurance
Free access to Novo Nordisk pharmaceutical products
Employee referral bonuses and long-term career development support
Company Overview:
Novo Nordisk is a global healthcare leader in diabetes and chronic disease care, offering cutting-edge pharma manufacturing and R&D solutions. The Bloomington, Indiana site specializes in clinical and commercial biomanufacturing, including drug product fill/finish and packaging, serving global patient populations.
Work Mode: On-site (3rd Shift – 11:00 PM to 7:30 AM, Sunday–Thursday)
Location: Bloomington, Indiana
Salary/Compensation: Not specified (competitive + bonus eligible)
Call to Action:
Looking to step into a high-impact QA role in pharmaceutical manufacturing? Apply now and bring your quality mindset to Novo Nordisk’s world-class operations.
Join us in shaping the future of healthcare.
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