Senior Quality Assurance Specialist

4 weken geleden


Leiden, Zuid-Holland, Nederland Oxford Global Resources Voltijd

Job Description:

The Oxford Global Resources team is seeking a skilled Senior Quality Assurance Specialist to join their European Quality Control team. As a key member of the laboratory team, you will play a crucial role in ensuring the highest standards in clinical trial support and quality management.

Responsibilities:

  • Provide expert Quality Control support for clinical trials, focusing on laboratory problem-solving and QC evaluations.
  • Oversee and manage quality documentation within the laboratory, including deviations, CAPAs, and change controls.
  • Author and review critical laboratory documentation related to European QC processes.
  • Approve and review standard operating procedures (SOPs) to ensure laboratory practices align with regulatory standards.
  • Act as a backup for laboratory QC training, ensuring all staff are well-versed in quality procedures.
  • Collaborate with cross-functional teams to ensure laboratory processes are aligned and effectively communicated.
  • Implement and oversee laboratory process improvements that meet regulatory requirements while enhancing efficiency and simplicity.

Requirements:

  • Bachelor's or Master's degree in Life Sciences, Biotechnology, or a related field.
  • Minimum of five years of experience in a pharmaceutical or biotechnology laboratory industry.
  • Expertise in quality record management and root cause investigation within a lab setting.
  • Hands-on experience with laboratory analytical techniques, including Flow Cytometry, PCR, and cell-based assays.
  • Fluent in English, with excellent communication skills.
  • Availability to work on site at least three days a week, with options for part-time work (32 hours minimum).

Benefits:

  • Salary range: €3400-€5500,- gross per month or a consultant payrate of €50,- per hour.
  • Six-month employment contract with potential for extension.
  • Flexible working arrangements.
  • Access to a state-of-the-art laboratory with the latest technology in the field.
  • Fulltime position, contract through Oxford Global Resources.
  • Location: Leiden.


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