QA Representative – Quality Management Systems
Location: Bloomington, Indiana, United States
Work Mode: On-site
Job Summary:
Novo Nordisk is seeking a QA Representative to lead and manage quality management systems, with a focus on TrackWise® administration, CAPA management, and regulatory compliance. This on-site role supports pharmaceutical quality initiatives through system optimization, internal audits, and process improvement. Ideal for professionals with hands-on GxP experience and a strong understanding of quality systems in a regulated biomanufacturing environment.
Key Responsibilities:
Oversee TrackWise® system as administrator, including user access, training, and audits.
Manage deviations, CAPA, and OOS investigations in alignment with cGMP and regulatory standards.
Maintain and continuously improve site-wide Quality Systems and related documentation.
Develop and report metrics to support quality system performance and compliance.
Lead cross-functional initiatives for process improvement and regulatory alignment.
Conduct routine reviews of system access and ensure system security and documentation accuracy.
Support document control activities and maintain controlled records.
Participate in quality improvement projects and other QA duties as assigned.
Required Skills & Qualifications:
Bachelor’s degree with 2+ years of experience, or Master’s degree with relevant background.
At least 1 year of GxP experience or other regulated industry required.
Experience in aseptic operations, deviation investigation, validation, and environmental testing preferred.
Strong knowledge of quality systems, CAPA, and pharmaceutical QA processes.
Must be proficient in:
TrackWise®, ComplianceWire®, and other QMS tools
MS Office (Excel, Word)
Reading and interpreting cGMP regulations
Data interpretation, trend analysis, and reporting
Perks & Benefits:
Competitive base salary with annual performance bonus
14 paid holidays + generous paid time off
Day-one coverage: Health, Dental, and Vision Insurance
401(k) with 8% guaranteed contribution + match
14 weeks paid parental leave, 6 weeks family medical leave
Tuition reimbursement and life & disability insurance
Free access to Novo Nordisk pharmaceutical products
Employee referral bonuses
Company Description:
Novo Nordisk, a global leader in diabetes care and chronic disease management, operates a state-of-the-art biomanufacturing facility in Bloomington, Indiana. The site supports full-scale drug product formulation, clinical and commercial manufacturing, and packaging – serving patients worldwide with high-quality pharma solutions.
Work Mode: On-site
Location: Bloomington, Indiana
Compensation: Not explicitly mentioned (competitive + bonus eligible)
Call to Action:
Step into a strategic quality role with global impact. Apply now to lead system-level quality initiatives at Novo Nordisk’s premier pharma manufacturing site.
Take the next step in your pharmaceutical QA career today.
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