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Quality Assurance Area Specialist I

Facility:  Quality
Location: 

West Lebanon, NH, US

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 will review manufacturing and support documentation and records to certify compliance with in-house specifications/standards and Good Manufacturing Practice (GMP) for all NNUSBPI products. This position has Quality Assurance (QA) signature authority on the review of individual batch records, supporting test records and other ancillary support records. Will assist in the internal audit program and be a QA presence on the manufacturing floor.

 

Relationships

Reports to: According to the organizational chart.

Number of subordinates with direct/indirect referral: n/a

 

Essential Functions

  • Participate in walk through audits of NNUSBPI Manufacturing facilities
  • Review and assess Corrective and Preventive Actions
  • Reviews and approves validation documentation
  • Reviews and assesses deviations; includes tracking, follow-up and reporting/trending
  • Reviews manufacturing and support records to certify compliance with specifications and procedures
  • Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the facility, and deviation issues
  • Assists in performing and reporting internal and vendor audits as scheduled
  • Participate in Regulatory Inspections
  • 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
  • Other duties as assigned

 

Physical Requirements

0-10% overnight travel required. 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.

 

Qualifications

  • Education and Certifications
    • Bachelor’s Degree (or equivalent) required, a scientific discipline preferred
  • Work Experience
    • A minimum of one (1) year of QA related experience, preferably within a pharmaceutical or biotechnology company.
  • Knowledge, Skills, and Abilities
    • 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
    • Ability to take and follow general instructions for routine work, and detailed instructions for new assignments
    • Strong planning and organization skills, with flexibility for changes in work priorities

 

Pay and level commensurate with experience. 

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.