Representative, Quality Assurance - Change Controls

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 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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including14 paid holidays
3. Health Insurance Dental Insurance Vision Insurance effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. Employee Referral Awards

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.

QA Representative Change Controls

The QA Representatives 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.

Essential Functions

• Facilitate and maintain the site change control process in compliance with FDA EU GMP and other regulatory guidelines.
• Manage change control records within the electronic quality management system and ensure timely review and closure.
• Facilitate the Change Control Board (CCB) activities ensuring thorough review and deci-sion-making regarding change risks impacts and action plans.
• Collaborate with cross-functional teams including Manufacturing Quality and Regula-tory to ensure change controls are well-documented traceable and compliant.
• Maintains and enhances 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
• Drives alignment and improvement initiatives leading cross function teams to address process improvement system improvement and new regulations/expectations
• Maintains a sufficient understanding of the quality systems and operations
• Assist with revision of GMP documentation such as Standard Operating Procedures
• Promotes teamwork a positive work environment and an atmosphere that enhances continuous improvement in aseptic quality and production environment
• Demonstrate and promote a Right the First Time culture while operating in a safe manner elevating all safety issues and concerns appropriately and in a timely manner
• Follow all SOPs cGMPs and remain current with all training requirements
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• Other duties as assigned

Physical Requirements

100% onsite at the Bloomington Indiana site.

Qualifications

• Bachelors degree and 2 years of experience or Masters 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 TrackWise or ComplianceWire required
• Ability to understand and independently apply CGMPs to everyday work required
• Intermediate understanding of pharmaceutical laboratory and/or production operations required
• Ability to contribute to investigations deviations and change controls with initial consultation from supervisor required
• Ability to problem solve and execute and monitor corrective action required
• Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions required
• Must be able to read and understand English-written job instructions and safety requirements required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Were not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability protected veteran status or any other characteristic protected by local state or federal laws rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.