QA Representative, Quality Management Systems

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

The QA Representative’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high-quality drug products for our clients and their patients.

Specifically, this role is responsible for overseeing the Track Wise system and spearheading projects related to the quality management system, including document management and change controls. Additionally, this person will grant access and provide training to staff as needed, as well as perform routine reviews and audits of user access levels.

Essential Functions

• Accountable for the Investigation and CAPA Management Systems (Track Wise).
• Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaborating with internal stakeholders to support the effective execution of the Investigation and CAPA systems.
• Maintain and enhance effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification, and CAPA processes.
• Drive alignment and improvement initiatives, leading cross-functional teams, to address process improvement, system improvement, and new regulations/expectations.
• Supports employees by serving as a Track Wise Administrator, providing access and training, as needed.
• Conduct periodic reviews/audits on users and access levels.
• File and maintain controlled documents.
• Other duties as assigned.

Physical Qualifications

100% onsite at the Bloomington, Indiana site.

Qualifications

• Bachelor's degree and 2+ years of experience or Master's degree and 0+ years of experience, required.
• Prior experience working in and/or supporting aseptic operations in a cGMP environment as it relates to cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation, environmental testing, and investigations, preferred.
• A strong working knowledge of quality systems and processes, preferred.
• GxP experience or other regulated industry, required.

Technical Requirements

• Ability to use Excel, Word, and other office systems, required.
• Ability to learn and use quality management software such as Track Wise or Compliance Wire, required.
• Ability to understand and independently apply CGMPs to everyday work, required.
• Intermediate…