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Quality Assurance Area Specialist I

1-3 years
Not Disclosed
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 developed and produced. This manufacturing facility supplies global markets with treatments for hemophilia and growth hormone therapies, along with next-generation medications. The site fosters a supportive community where ethics and quality are prioritized to improve patients' lives.

Novo Nordisk offers opportunities, resources, and mentorship for employees to grow and reach their potential. The company is looking for individuals with a strong work ethic and a self-starting attitude to join their team.

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.
  • Guaranteed 8% 401K contribution, with an individual company match option.
  • 14 weeks paid parental leave.
  • Free access to Novo Nordisk-marketed pharmaceutical products.

Position Overview:

This position is responsible for reviewing manufacturing and support documentation to ensure compliance with in-house specifications, standards, and GMP for all NNUSBPI products. The role includes QA signature authority on the review of batch records, supporting test records, and other related documentation. Additionally, the position will assist in the internal audit program and provide QA support on the manufacturing floor.

Reports To: Manager, Quality Assurance
Subordinates: None


Key Responsibilities:

Documentation and Compliance:

  • Review and assess Corrective and Preventive Actions (CAPA).
  • Approve validation documentation.
  • Review, track, and assess deviations, including follow-up and reporting/trending.
  • Review manufacturing and support records to ensure compliance with specifications and procedures.

Collaboration and Auditing:

  • Participate in walk-through audits of NNUSBPI manufacturing facilities.
  • 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.

Regulatory and Ethical Compliance:

  • Participate in Regulatory Inspections.
  • Perform all job duties in compliance with applicable healthcare laws, regulations, and industry codes.
  • Incorporate the Novo Nordisk Way and 10 Essentials in all activities and interactions.

Other Responsibilities:

  • Additional duties as assigned.

Physical Requirements:

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

Qualifications:

Education:

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

Experience:

  • Minimum of one (1) year of QA-related experience, preferably in a pharmaceutical or biotechnology company.

Skills and Abilities:

  • Excellent written and verbal communication and negotiation skills.
  • Ability to exercise judgment based on defined practices and policies.
  • Ability to follow general instructions for routine work and detailed instructions for new assignments.
  • Strong planning and organization skills, with flexibility to adjust priorities as needed.