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Experienced Quality Assurance Specialist

2 months ago

Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking an experienced Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our Quality Control department, you will be responsible for ensuring the analytical performance and equipment meet industry standards, GMP, and regulatory requirements.

Key Responsibilities

  • Product responsible: Ensure understanding of the relationship between product and the QC analyses
  • Continuously improve and optimize our processes
  • Qualify, validate, and implement respective analytical equipment and analysis methods
  • Participate in projects and collaborate with stakeholders across the organization
  • Approve analytical results and secure their timely delivery
  • Participate in and facilitate systematic problem solving (SPS)
  • Assist in the preparation of documentation for customers and authorities
  • Present documentation during inspections and audits

Requirements

  • A scientific academic degree such as cand. pharm., cand. scient., chemical engineer or similar; a Ph.D. in a relevant area could be an advantage
  • Experience from a GMP-regulated laboratory
  • Working experience as an analytical chemist with techniques such as HPLC, GC, titration, and Spectrophotometer. Experience with analysis of enzymes is an advantage
  • Relevant LEAN experience from a comparable position or education, combined with a natural eye for upscaling work processes and reduce waste
  • Strong communication skills and professionally proficient in both written and spoken Danish and English

About the Department

We are a well-functioning department, and you will be joining a team of 10 highly professional and motivated chemists, lab technicians, and an Analytical Coordinator who support the development of products and production with high-quality assays. The team also handles tasks like stability tests, raw material controls, input to regulatory documentation, implementation of new analytical equipment and software, CMO collaboration, development, and validation of methods, etc.

What We Offer

As a Quality Assurance Specialist at Novo Nordisk A/S, you will have the opportunity to work in a dynamic environment with a high degree of contact with colleagues both inside and outside the team. You will be part of a team that is committed to delivering high-quality products and services, and you will have the opportunity to contribute to the development of our processes and procedures.