Principal Representative, QA-Sterility

Shift

Sunday-Thursday 7AM-4PM

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.

As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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 including 14 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.

The Quality Assurance department is responsible for all aspects of the quality assurance functions. The department’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.

Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, supplier quality management, raw material testing and disposition, and training, as well as oversight of the equipment calibration and preventive maintenance program and validation activities.

Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, and process validation activities.

• Essential Functions

• This role will offer you:
  • A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives.
  • The scope to work with a cross functional team to develop and establish the sterility assurance program for a state-of-the-art Pharmaceutical manufacturing facility ensuring excellent compliance
• You will be responsible for:
  • Working with a team to develop and implementing sterility assurance strategies, policies, and procedures for the company's manufacturing facility.
  • Assisting leadership in the implantation of quality systems procedures and handling compliance across the department
  • Being a strong member of a team of sterility assurance and aseptic operations professionals
  • Participate in regulatory inspections and assist in leading the quality assessment of internal operations for any risks
  • Responsible with the team for the Contamination Control Strategy and Sterility Assurance to ensure and improve clean room controls within the facility to minimize risk and cross-contamination
• Desirable experience and qualifications:
  • 8 plus years in and aseptic processing within pharmaceutical/biotech manufacturing
  • BS degree in Science, preferably in Sterility
  • Proven experience managing and leading teams
  • Strong regulatory knowledge of industry standards related to sterile manufacturing and aseptic processing
  • Experience with regulatory inspections and audits
• Job Type: Full-time

• Physical Requirements
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.  Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed. Walking and/or standing for up to 8 to 12 hours depending on assigned area. Successful completion of gowning certification to enter and support the aseptic manufacturing areas.

• Qualifications

•          8 plus years with Sterility and aseptic processing within pharmaceutical/biotech manufacturing
  • BS degree in Science, preferably in Microbiology
  • Proven experience managing and leading teams
  • Strong regulatory knowledge of industry standards related to sterile manufacturing and aseptic processing
  • Experience with regulatory inspections and audits

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.