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Associate Representative, Quality Assurance

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 (3rd Shift)

Location: Bloomington, Indiana, United States
Work Mode: On-site | Shift: 3rd Shift (11:00 PM – 7:30 AM, Sun–Thurs)

Job Summary:

Novo Nordisk’s Bloomington facility is hiring a Quality Assurance Associate Representative for the 3rd shift. This role provides direct GMP floor oversight, batch record review, and supports supplier quality and audit readiness in a dynamic, regulated manufacturing environment. If you are quality-focused with strong attention to compliance, this is a growth-focused opportunity in one of the most advanced pharma manufacturing facilities in the U.S.


Key Responsibilities:

  • Conduct floor QA oversight for manufacturing, including cell banks and drug product processes.

  • Review and release incoming materials; assess damaged materials and manage holds.

  • Execute GMP documentation reviews, room releases, and deviation initiation.

  • Support supplier management, audit prep, and CAPA processes.

  • Perform Gemba walks, AQL visual inspections, and on-the-floor batch reviews.

  • Participate in internal and client audits (front room and back room roles).

  • Lead quality improvements and participate in cross-functional initiatives.

  • Assist in SOP and GMP documentation updates and process validations.

  • Ensure compliance with all safety, regulatory, and environmental requirements.


Required Skills & Qualifications:

  • Education:

    • Bachelor’s degree preferred

    • 0–2 years of experience; 1+ year in GxP or regulated environment

  • Technical Skills:

    • Working knowledge of CGMPs, SOPs, and documentation practices

    • Proficient in Excel, Word, and quality systems (e.g., TrackWise®, ComplianceWire®)

    • Strong problem-solving, trend analysis, and quality system navigation skills

    • Capable of interpreting data, contributing to investigations, and editing SOPs

  • Behavioral Skills:

    • Strong communication, organization, and time management

    • Ability to work independently or in teams under pressure and deadlines

    • Proactive approach to compliance and continuous improvement


Perks & Benefits:

  • Competitive salary with annual performance bonus

  • 14 paid holidays plus generous PTO

  • Health, Dental & Vision Insurance effective Day 1

  • 8% guaranteed 401(k) contribution with employer match

  • 14 weeks Paid Parental Leave + 6 weeks Paid Family Medical Leave

  • Free access to Novo Nordisk pharmaceutical products

  • Tuition assistance, life & disability insurance, and referral awards


Company Overview:

Novo Nordisk is a global healthcare leader in diabetes care and chronic disease treatment. The Bloomington, IN site is a high-tech facility driving drug product development, fill/finish, and commercial manufacturing for global patients. With a focus on innovation, quality, and compliance, Novo Nordisk offers meaningful work with a global impact.


Work Mode: On-site (3rd Shift)

Location: Bloomington, Indiana
Salary Range: Not specified (competitive + bonus eligible)


Call to Action:

Are you detail-oriented and passionate about pharmaceutical quality? Join Novo Nordisk in ensuring product excellence and patient safety.
Apply now and be part of a life-changing mission.