Quality Assurance Area Specialist Ii

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications.

What we offer you:

• 34 Paid days off including vacation, sick days & company holidays
• Leading pay and annual performance bonus for all positions
• Guaranteed 8% 401K contribution plus individual company match option
• Free access to Novo Nordisk-marketed pharmaceutical products
• 12 weeks Paid Parental Leave
• Health Insurance, Dental Insurance, Vision Insurance

At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the manufacturing floor.

Essential Functions

• Performs walk-through audits of NNUSBPI Manufacturing facilities
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Reviews manufacturing and support records to certify compliance with specifications and procedures
• Review and assess Corrective and Preventive Actions
• Reviews and assesses deviations; includes tracking, follow-up and reporting/trending
• Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Assists in performing and reporting internal and vendor audits as scheduled
• Participate in Regulatory Inspections
• Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance
• Reviews and approves validation documentation
• Other duties as assigned

Physical Requirements

While performing this job employee work involves sitting most of the time with walking and standing required only occasionally. This position may lift up to 10 pounds occasionally or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, and analyzing. Local and International travel: 0-5%.

Qualifications

• Normally receives little to no instructions for routine work, and general instructions for new assignments
• Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors
• Excellent written and verbal communication and negotiating skills are required
• Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
• Strong planning and organization skills, with flexibility for changes in work priorities
• Bachelor’s Degree (or equivalent) required, a scientific discipline preferred
• A minimum of three (3) years of GMP-related experience in a pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience

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.