Senior Quality Assurance Specialist
4 weken geleden
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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