Quality Assurance Area Specialist I

Novo Nordisk • Lebanon, NH

423d

About The Position

The Quality Assurance Area Specialist I at Novo Nordisk is responsible for reviewing manufacturing and support documentation to ensure compliance with internal specifications and Good Manufacturing Practices (GMP) for all NNUSBPI products. This role includes QA signature authority on batch records and supporting documents, assisting in internal audits, and maintaining a QA presence on the manufacturing floor.

Requirements

• Bachelor's Degree (or equivalent) required, preferably in a scientific discipline
• A minimum of one (1) year of QA related experience, preferably within a pharmaceutical or biotechnology company
• Excellent written and verbal communication and negotiating skills
• Ability to exercise judgment within defined practices and policies
• Strong planning and organization skills with flexibility for changes in work priorities

Responsibilities

• Participate in walk through audits of NNUSBPI Manufacturing facilities
• Review and assess Corrective and Preventive Actions
• Review and approve validation documentation
• Review and assess deviations, including tracking, follow-up, and reporting/trending
• Review manufacturing and support records to certify compliance with specifications and procedures
• Work closely with Manufacturing and Quality Control to resolve open issues from record reviews and audits
• Assist in performing and reporting internal and vendor audits as scheduled
• Participate in Regulatory Inspections
• Perform all job duties in a compliant and ethical manner according to healthcare laws and regulations
• Incorporate the Novo Nordisk Way and 10 Essentials in all activities

Benefits

• Leading pay and annual performance bonus
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees