Quality Assurance Area Specialist III

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Job description

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. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We're looking for individuals who are self-starters with a strong work ethic to join our team. 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.

Relationships

Quality Assurance.

Essential Functions

• Reviews all manufacturing and support records to certify compliance with specifications and procedures
• Releases product based on Quality Assurance record review and approval by QA Manager
• Performs regular internal audits of NNUSBPI facilities as a lead auditor
• Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues
• Performs vendor audits as scheduled
• Reviews and assesses Deviations, including evaluation, tracking, follow-up, and reporting / trending. Possess signature authority for deviation closure
• Reviews and approves Validation Documentation
• Reviews and assesses Corrective and Preventive Action Reports
• Participates in Regulatory Inspections
• Other duties as assigned
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Physical Requirements

Local and International travel: 0-5%. The ability to stand, crouch, walk, and lift. 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 frequently or constantly to lift, carry, push, pull or otherwise move objects. Visual acuity to perform close activities such as: reading, writing, verification and analyzing.

Qualifications

• Education and Certifications:
• Bachelor's Degree (or equivalent) required, a scientific discipline preferred

Work Experience:

A minimum of five (5) years of GMP-related experience in a pharmaceutical or biotechnology company, with three (3) years of direct QA experience

Experience in a licensed drug or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred

As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and Production documentation and processes

• Knowledge, Skills, and Abilities:
• Excellent written and verbal communication and negotiating skills are required
• Strong planning and organization skills, with flexibility for changes in work priorities
• Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken
• Normally receives no instructions on routine work, and general instructions on new assignments. Determines and develops approach to solutions
• Ability to work on complex Quality projects where analysis of data requires evaluation of identifiable factors

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

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