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.
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