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 produces life-saving treatments, including a global supply of hemophilia and growth hormone therapies, as well as cutting-edge medications. The site is known for its tight-knit, supportive community, where ethics and quality are the guiding principles. Novo Nordisk fosters a patient-focused mindset and is looking for self-starters with strong work ethics to join the team and contribute to a better tomorrow for patients.

Benefits:

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
8% guaranteed 401K contribution, plus an individual company match option
14 weeks of paid parental leave
Free access to Novo Nordisk-marketed pharmaceutical products

Position Overview:

This role involves performing reviews of manufacturing and support documentation to certify compliance with in-house specifications, standards, and GMP for all NNUSBPI products. The position includes QA signature authority for reviewing batch records, supporting test records, and other ancillary support records. The role also requires QA presence on the manufacturing floor.

Key Responsibilities:

Documentation and Compliance:

Review manufacturing and support records to ensure compliance with specifications and procedures.
Release products based on QA record review and approval by the QA Manager.
Approve validation documentation and assess Corrective and Preventive Actions.
Review and assess deviations, tracking follow-up, reporting/trending, and having signature authority for deviation closure.

Auditing and Collaboration:

Perform regular internal audits as a lead auditor.
Work closely with Manufacturing and Quality Control to resolve issues arising from record reviews, audits, and deviations.
Conduct vendor audits as scheduled.

Regulatory and Ethical Compliance:

Participate in Regulatory Inspections.
Perform all job duties in a compliant and ethical manner, adhering to healthcare laws, regulations, and industry codes.
Integrate the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.

Other Duties:

Additional tasks as assigned.

Physical Requirements:

Local and international travel: 0-5%.
Ability to stand, crouch, walk, and lift up to 10 pounds.
Mostly desk-based work with occasional walking and standing.
Visual acuity for activities like reading, writing, and analysis.

Qualifications:

Education:

Bachelor’s Degree (or equivalent) required, preferably in a scientific discipline.

Experience:

Minimum of five (5) years of GMP-related experience in a pharmaceutical or biotechnology company.
At least three (3) years of direct QA experience.
Experience in a licensed drug or biologic facility regulated by FDA, EMEA, or other international regulatory agencies preferred.
Knowledge of Quality Assurance oversight and support for clinical and production documentation.

Skills and Abilities:

Excellent written and verbal communication and negotiation skills.
Strong planning and organization skills with flexibility to adjust to changes in work priorities.
Ability to exercise sound judgment within defined practices and policies.
Ability to work on complex Quality projects requiring data analysis and evaluation.
Independently determines and develops approaches to solutions.

Equal Opportunity Employer:

Novo Nordisk is committed to a recruitment process that promotes diversity and equality of opportunity for all applicants. Qualified candidates will receive consideration for employment 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 require special assistance or accommodations to apply, please contact 1-855-411-5290. This line is for accommodation requests only and cannot be used to inquire about the status of applications.

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