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Quality Management Systems Analyst Iii

6+ years
Not Disclosed
10 July 8, 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

 

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.