Quality Assurance Area Specialist I/II/III
Novo Nordisk
- West Lebanon, NH
- Permanent
- Full-time
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Quality Assurance Area Specialist I/II/IIIFacility: QualityLocation:West Lebanon, NH, USAbout the DepartmentSite 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
- 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
- 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