Quality Assurance Area Specialist I

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:

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

 

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 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 assist in the internal audit program and be a QA presence on the manufacturing floor.

 

Relationships

According to the organizational chart.

 

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

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

• 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