Senior Sterility Assurance Representative, QA, 10pm - 8:30am, Monday Thru Friday

Novo Nordisk Job Opportunity

At Novo Nordisk, we are committed to making a difference in diabetes care for over 100 years. Our Bloomington, Indiana site is a state-of-the-art facility where talented teams work with innovators to help develop, manufacture, and supply products to patients around the world.

What We Offer You:

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

Sterility Assurance Department

The Sterility Assurance department is responsible for all aspects of the quality/sterility 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

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. The 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. The 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. The 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 oversee, document and track the sterility assurance program for a state-of-the-art Pharmaceutical manufacturing facility ensuring excellent compliance.

Responsibilities

You will be responsible for:

• Observation and coaching of aseptic behavior during normal production and Aseptic Process Simulations (APS) / media fills
• Advising on sterility assurance and microbiological protocols and procedures
• Assisting leadership in the implantation of quality systems procedures and handling compliance across the department
• Authoring and updating departmental documents to ensure compliance with site, global, and regulatory requirements
• Proposing corrective and preventive actions to improve contamination controls
• Maintaining formal traceability of observations and informing management
• Responsible with the team for the Contamination Control Strategy and Sterility Assurance to ensure and improve clean room controls and behaviors within the facility to minimize risk, contamination and cross-contamination

Qualifications

Desirable experience and qualifications:

• Experience (5+ years) with aseptic processing within pharmaceutical/biotech manufacturing
• BS degree in Science, preferably in Microbiology
• 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 aseptically gown and operate within a clean room environment as needed.
• Walking and/or standing for up to 8 to 10 hours depending on assigned area.
• Successful completion of gowning certification to enter and support the aseptic manufacturing areas.

Novo Nordisk is committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and communities we operate in. 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. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.