Eurofins Netherlands BioPharma Product Testing - Leiden
Job Description As QA Specialist you maintain a GMP compliant Quality Management System for the manufacturing and testing of raw materials and (biological) drug products based on applicable regulations and guidelines. You - Volledige vacature bekijken
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QA manufacturing specialist
Join our client as a Manufacturing Specialist for CAR-T cell therapies in Leiden. You will provide QA support through clinical manufacturing and technology transfers, production training, and material management. If you have excellent verbal and written communication skills, a self-motivated attitude, and a desire to make a difference in the lives of patients, then we want to hear from you!
Job Description
The Manufacturing Specialist will provide operational expertise to our client's decentralized point-of-care manufacturing units for CAR-T cell therapies. The role involves critical technical support through clinical manufacturing and technology transfers, subject matter expertise in aseptic training, production training, and material management, as well as a strong commitment to patients.Responsibilities
- Provide technical support for GMP activities at the decentralized point-of-care manufacturing sites, including equipment qualification, production training, aseptic process validation, process qualification runs and operational readiness.
- Offer technical support services for the decentralized point-of-care manufacturing sites, providing front-line troubleshooting, deviation management, escalation, coordination of subject matter experts to ensure timely release of CAR-T products meeting quality/regulatory requirements.
- Collaborate closely with Quality Assurance and other departments to support the release of different products. Support implementation of change controls and CAPA.
- Contribute with technical training both, hands-on as well as documentation. Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform.
- Write and review electronic batch records, SOPs, protocols & reports.
Requirements
- Bachelor's or Master's degree in life sciences, biotechnology, engineering or related discipline.
- Experience with GMP manufacturing, cell & gene therapy processes, biotechnology products, technology transfer, aseptic processing, and technical writing.
- Ability to prioritize effectively and be flexible with changing priorities.
- Good interpersonal skills, including verbal and written communication, are essential in this collaborative environment.
- Spoken fluency in English.
- Self-motivated with a can-do mindset, without compromising quality and compliance.
- Understanding of ERP, equipment qualification lifecycle is a plus.
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