Quality Assurance Area Specialist Iii

3-5 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 New Hampshire Site in West Lebanon is where life-saving treatments are brought to life. This manufacturing facility is responsible for producing a global supply of hemophilia and growth hormone product lines, as well as the next generation of cutting-edge medications. The site operates as a tight-knit, supportive community, emphasizing ethics, quality, and a patient-focused mindset in all activities. Novo Nordisk offers opportunities for growth, resources, and mentorship for those who are self-starters and have a strong work ethic.

Benefits:

Opportunities for career growth and development
Access to mentorship and resources

Position Overview:

This role is responsible for reviewing manufacturing and support documentation and records to ensure compliance with internal specifications/standards and Good Manufacturing Practices (GMP) for all Novo Nordisk products. The position holds QA signature authority and provides a QA presence on the manufacturing floor.

Reports To: Manager, Quality Assurance
Subordinates: None

Key Responsibilities:

Documentation and Compliance:

Review manufacturing and support records to ensure compliance with specifications and procedures.
Approve the release of products based on quality assurance record reviews.
Perform regular internal audits as a lead auditor.
Review, track, and assess deviations, including follow-up and reporting/trending.
Provide signature authority for deviation closures.
Review and approve validation documentation and Corrective and Preventive Action Reports (CAPA).

Collaboration and Auditing:

Work closely with Manufacturing and Quality Control to resolve open issues related to record reviews, audits, and deviations.
Perform vendor audits as scheduled.
Participate in regulatory inspections.

Ethical and Compliant Behavior:

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

Other Responsibilities:

Additional duties as assigned by the manager.

Physical Requirements:

Local and international travel: 0-5%.
Ability to stand, crouch, walk, and lift up to 10 pounds frequently or constantly.
Visual acuity required for tasks such as reading, writing, and verification.
Mostly desk-based work, with occasional walking and standing.

Qualifications:

Education:

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

Experience:

Minimum of five (5) years of GMP-related experience in a pharmaceutical or biotechnology company.
At least three (3) years of direct Quality Assurance experience.
Experience in a licensed drug or biologic facility regulated by the FDA, EMEA, or other leading international regulatory agencies is preferred.
Experience with QA oversight and support for all phases of Clinical and Production documentation and processes is a plus.

Skills and Abilities:

Excellent written and verbal communication and negotiation skills.
Strong planning and organization skills with flexibility to adapt to changing priorities.
Ability to exercise judgment within defined practices and policies.
Ability to work on complex Quality projects that involve data analysis and evaluation.
Independently determine and develop approaches to problem-solving and solution development.

Equal Opportunity Employer:

Novo Nordisk is an equal opportunity employer and is committed to creating an inclusive culture that celebrates diversity and equality. All applicants will be considered without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, 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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