Quality Assurance Area Specialist IV

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.

 

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