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Associate Representative, Quality Assurance (Multiple Openings)

0-2 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 (Multiple Openings)

Location: Bloomington, Indiana, United States
Work Mode: On-site | Multiple Shifts Available

Job Summary:

Novo Nordisk is hiring multiple Associate Representatives in Quality Assurance to support product quality operations at its advanced biomanufacturing site in Bloomington, IN. This entry-level QA opportunity is ideal for professionals with GxP experience seeking to grow their careers in a GMP-compliant pharmaceutical environment. The role provides essential QA support for production, documentation review, audits, and quality system processes.


Key Responsibilities:

  • Collaborate with Supply Chain, QC, and Materials Management for material readiness

  • Conduct Gemba walks and assess damaged materials in warehouse settings

  • Maintain approved supplier lists and assist in audits and documentation

  • Review batch records and ensure corrections and specifications are properly addressed

  • Ensure finished products meet regulatory and client requirements

  • Support QA on the Floor program and issue production documentation

  • Interact with clients professionally for post-disposition corrections

  • Enforce compliance with cGMP, internal SOPs, and safety protocols


Required Skills & Qualifications:

  • Bachelor’s degree in STEM (preferred) with 0–2 years’ experience

  • Minimum 2 years of GxP or regulated industry experience required

  • Working knowledge of cGMPs, deviation investigations, validation, and documentation

  • Proficient in Microsoft Office (Excel, Word)

  • Familiarity with QMS tools like TrackWise®, ComplianceWire®

  • Strong written and verbal communication skills

  • Analytical thinking and problem-solving capabilities

  • Able to multitask and work in high-pressure, deadline-driven environments

  • Experience with aseptic operations in a cleanroom setting preferred


Perks & Benefits:

  • Competitive pay and annual performance bonus

  • 14 paid holidays plus generous PTO

  • Day-one health, dental, and vision coverage

  • 8% guaranteed 401(k) contribution + company match

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

  • Tuition assistance, life & disability insurance

  • Free access to Novo Nordisk-marketed pharma products

  • Employee referral rewards


Company Description:

Novo Nordisk is a globally renowned pharmaceutical company focused on diabetes and chronic disease management. Its Bloomington, Indiana site supports the end-to-end development and manufacturing of clinical and commercial drug products. This modern biomanufacturing campus delivers high-quality, GMP-compliant products that reach patients worldwide.


Work Mode: On-site

Shift Options: Weekday AM/PM, Weekend AM/PM
Location: Bloomington, Indiana
Compensation: Competitive (exact range not disclosed)


Call to Action:

Start your pharmaceutical quality career with a global leader. Apply now for this exciting QA opportunity at Novo Nordisk and help ensure the delivery of life-saving treatments.
Apply today and make a difference in healthcare quality assurance.