QA Internship (closed), Leiden

Are you passionate about conducting high quality science in a structured environment, to bring solutions to patients worldwide? Do you pay attention to detail and are passionate about bringing structure to chaos? And are you curious to know more about the world of quality and compliance in life sciences?Join our dynamic molecular diagnostics start-up as a Quality Assurance Intern and help support the development of our novel molecular point of care device for diagnosis of prevalent sexually transmitted infections. This internship offers a unique opportunity to get acquainted with the field of QA/QC and regulations, work closely with external consultants and contribute to the implementation of ISO 13485 certified processes. Get ready to make a significant impact on our organization’s quality standards and be at the forefront of molecular diagnostics innovation.Location: Leiden Bioscience Park Type: Internship - Suitable for thesis Length: 4-9 months Time: 40 hours/week Starting date: April-May 2024 Responsibilities

Become acquainted with the IVDR and relevant ISO certifications for IVD medical devices, and other relevant software solutions (eQMS) Support the team in setting up an operational and ISO 13485-compliant Quality Management System for our new molecular diagnostic POCT medical device. Collaborate with external consultants to establish a robust Quality Management System.Develop and implement Standard Operating Procedures (SOPs) to ensure adherence to quality standards. Ensure compliance with Good Laboratory Practices. Engage in the documentation and optimization of processes to meet regulatory requirements. Demonstrate strong organizational and structured work skills to independently manage tasks.Support in various aspects of quality assurance, ensuring the timely and accurate completion of assigned projects. Profile

A degree in molecular biology, biochemistry, or a other related field. A track record of thriving independently, showcasing initiative and proactive problem-solving skills. Exceptional organizational and time management skills to navigate the complex landscape of QA tasks. A deep-seated familiarity with molecular biology and assay development processes.Offer

Duration: Internship starts in Q1 2024 and lasts between 4 and 7 months. Learning Opportunity: Gain hands-on experience in setting up a QMS, implementing ISO 13485 processes, and contributing to a cutting-edge molecular diagnostics start-up. Supervision: Receive mentorship and support from experienced professionals in the field.Independence: Take ownership of projects, fostering a sense of autonomy and self-driven growth. Networking: Build connections within the industry and work alongside external consultants to broaden your professional network.

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