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High-Quality Manufacturing Specialist Position for Cancer Diagnostics

1 month ago


Glostrup, Glostrup Kommune, Denmark Agilent Full time

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise.

We are seeking a skilled Manufacturing QA Specialist to join our team in developing innovative solutions for pathology labs worldwide to improve cancer diagnostics. As a key member of our Quality Assurance department, you will work closely with manufacturing departments related to producing different kinds of intermediates and finished products used for in vitro diagnostic of cancer.

The ideal candidate will have a strong understanding of good manufacturing practice (GMP), regulatory requirements and industry standards such as ISO 13485 and MDSAP. You will apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities, ensuring site compliance with regulations and maintaining a high level of quality in our products.

We offer an inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing, and sustain activities. Our company is built on integrity, sharing, and trust, and we encourage collaboration between line of business and QA to drive continuous improvement.

This role offers a unique opportunity to make a significant impact in the field of cancer diagnostics. You will be part of a fast-paced environment where no two days are ever the same. If you thrive in a dynamic setting and are passionate about delivering high-quality results, this could be the perfect fit for you.

We estimate the salary for this position to be around $110,000-$140,000 per year, depending on experience and qualifications. Please note that job levels may vary based on relevant experience and qualifications.

Key Responsibilities:
  • Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
  • Ensure site compliance with Regulations, ISO standards, local standard operating procedures (SOPs).
  • Serve as the Subject Matter Expert (SME) of multiple quality processes.
Required Skills and Qualifications:
  • Bachelor's or master's degree in a Quantitative/Scientific/Technical discipline.
  • +2 years of work experience in the medical device or pharmaceutical industry.
  • Strong knowledge and understanding of standards and regulations: ISO 13485, Regulation (EU) 2017/746, ISO 14971:2019 and regulations covered under MDSAP.
Benefits:
  • An inspiring and social environment with around 40 skilled colleagues in the QA department.
  • A unique opportunity to make a significant impact in the field of cancer diagnostics.
  • A role among passionate colleagues, in a growth-oriented and inclusive environment.