Sterility Assurance Specialist

1 week geleden

Amersfoort, Utrecht, Nederland Applied Medical Voltijd
Job Title: Junior Sterility Assurance Specialist

At Applied Medical, we are seeking a highly motivated and detail-oriented Junior Sterility Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of sterility and quality in our cleanroom environment.

Responsibilities:
  • Coordinate and perform cleanroom microbial testing and activities to ensure compliance with regulatory requirements.
  • Oversee product bioburden and radiation dose audit testing to ensure the highest standards of quality.
  • Coordinate cleanroom certification activities to maintain our certification status.
  • Collect, compile, and summarize data and trends to inform quality improvement initiatives.
  • Provide structured analytical data on a regular basis, applying QMS processes to drive continuous improvement.
  • Assist with performing root cause analysis and propose corrective and preventative actions to address quality issues.
  • Decontaminate returned products prior to complaint investigation to ensure the highest standards of quality.
  • Ensure compliance with all applicable standards and regulations, including ISO 14644 and FDA regulations.
Requirements:
  • Bachelor's degree (HBO) in a scientific discipline or similar.
  • At least 1 year of experience in a controlled and regulated environment.
  • Excellent oral and written communication skills in English.
What We Offer:
  • An international working environment with a healthy work-life balance.
  • 27 paid vacation days (based on fulltime contract) with option to purchase five additional days.
  • Optional hybrid model, including home office equipment and a working from home allowance.
  • Commuting allowance of €0.23/km or an NS Business card subscription.
  • A wide variety of internal trainings and development possibilities and a tuition program for external trainings.
  • The opportunity to pro-actively work on your vitality and fitness.
  • State-of-the-art facilities, including green areas, in-house restaurant, and gym.
  • Additional benefits, such as an attractive pension scheme, health insurance contribution, and volunteering days.

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