Associate Representative, Quality Assurance

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:

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.

About The Position

Available Shifts:This will be the initial shift but may change in the future due to business needs so candidates must be flexible for shift changes including working weekends.

Weekday AM 6AM 6PM Mon Wed (week 1) then 6AM 6PM Mon-Thur (week 2)

Weekday PM 6PM 6AM Mon Wed (week 1) then 6PM 6AM Mon-Thur (week 2)

Weekend AM 6AM 6PM Fri- Sun

Weekend PM 6PM 6AM Fri-Sun

Relationships

Reports to a Manager within the QA department.

Essential Functions

• Collaborates with Quality Control Materials Management Supply Chain and Manufacturing to ensure that materials are available for use
• Assists in the customer and supplier auditing process providing administrative support including information gathering and organization
• Provide quality support to Quality Control Materials Management Center and Supply Chain
• Gather and report area metrics
• Support maintenance of the approved supplier list
• Assess damaged materials / product within warehouse spaces
• Perform routine Gemba walks of warehouse spaces
• Perform system cold storage equipment and material holds as appropriate
• Follow all safety and environmental requirements in the performance of duties
• Other duties as assigned

• Product Quality
• Accountable for ensuring that Finished Products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements
• Maintains a sufficient understanding of the quality systems and operations to provide consultation and guidance for Manufacturing personnel regarding execution of the Quality Management Systems
• Supports execution of QA on the Floor program
• Supports issuance of controlled documents for production including Batch Production Records Product Labels and forms
• Reviews executed batch records
• Ensures all in-process specifications are met
• Ensures all corrections found are made to batch records
• Interacts with clients in a professional manner to ensure timely resolution of post-disposition corrections

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

• Bachelors Degree required
• In lieu of Bachelors degree may consider High School diploma or equivalent education with minimum 4 years of pharmaceutical production/QA/QC experience required.
• Little to no experience required with bachelors degree but 2-years of GxP experience or other regulated industry preferred
• Ability to comprehend and follow job instructions and safety requirements provided in English required
• Analytical and problem-solving skills with the ability to make informed decisions based on experience and adherence to site processes and procedures.
• Strong written and verbal communication skills enabling effective sharing of vision direction and data with colleagues at all levels including interactions with senior leadership and regulatory agencies across diverse work groups
• Interpersonal skills organizational skills and project management skills with the ability to balance multiple priorities and projects
• 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

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