Quality Assurance Area Specialist Ii

3+ years

Not Disclosed

Remote United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance (QA) Role

Location: West Lebanon, United States

Department: Quality

Job Category: Quality

About the Department:

Novo Nordisk’s manufacturing facility in West Lebanon, New Hampshire, plays a critical role in the production of life-saving treatments. The site produces a global supply of hemophilia and growth hormone product lines, as well as innovative next-generation medications. Novo Nordisk focuses on delivering cutting-edge treatments to patients while maintaining a high standard of quality and care.

Benefits Offered:

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

Position Overview:

The Quality Assurance (QA) Role is responsible for reviewing manufacturing and support documentation to ensure compliance with in-house specifications/standards and Good Manufacturing Practices (GMP) for all Novo Nordisk products. This position holds QA signature authority and will serve as a QA presence on the manufacturing floor.

Reports To: Manager, Quality Assurance
Subordinates: None

Key Responsibilities:

Documentation and Compliance:

Perform walk-through audits of NNUSBPI Manufacturing facilities.
Review and approve manufacturing batch records, supporting test records, and other documentation.
Release products based on Quality Assurance record review and approval.
Review and assess Corrective and Preventive Actions (CAPA), validation documentation, and deviations.
Track, follow-up, and report/trend deviations.

Collaboration and Auditing:

Work closely with Manufacturing and Quality Control teams to resolve issues arising from record reviews and audits.
Assist in performing and reporting internal and vendor audits as scheduled.
Participate in regulatory inspections and ensure compliance during inspections.

Ethical and Compliant Behavior:

Perform duties in accordance with all applicable healthcare laws, regulations, and industry codes.
Incorporate the Novo Nordisk Way and 10 Essentials into all interactions.

Other Responsibilities:

Other duties as assigned.

Physical Requirements:

Primarily a desk-based role with occasional walking and standing.
Ability to lift up to 10 pounds occasionally.
Requires visual acuity for close tasks such as reading, writing, and analysis.
Local and international travel: 0-5%.

Qualifications:

Education:

Bachelor’s Degree (or equivalent) required; scientific discipline preferred.

Experience:

Minimum of three (3) years of GMP-related experience in a pharmaceutical or biotechnology company.
At least one (1) year of direct Quality Assurance experience.

Skills and Abilities:

Ability to analyze data and work on quality projects with identifiable factors.
Strong written and verbal communication and negotiation skills.
Ability to exercise judgment within defined practices and policies.
Ability to work independently with minimal guidance for routine tasks.
Strong planning, organizational skills, and flexibility for changing priorities.

Equal Opportunity Employer:

Novo Nordisk is an equal opportunity employer and offers equal 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 law.

Special Assistance:

If you need special assistance or accommodations to apply, please contact us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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