Yacht Life Sciences has a vacancy for a Release & Stability Analyst QC at Johnson & Johnson in Leiden.
As a Release & Stability Analyst QC, you:
- Fully own end-to-end product testing process within Leiden QC with some support.
- Coordinate the release of raw materials drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.
- Coordinate the stability testing of JSC large molecule products according to local procedures and agreed timelines.
- Act as subject matter expert on release and stability processes and has a leading role during the GMP inspections.
- Participate in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience.
- Are responsible to coordinate all data requests provided by various stakeholders (e.g. RA; Health Authority; DPDS ) and have the accountability to plan, organize, prioritize and execute the data Requests based on the stakeholder requests.
- Responsible for reviewing the CPV plans and matrixes and update the QC release trend limits accordingly.
Furthermore, you will:
- Provide input for the YBPR and APR requests.
- Lead and drive continuous improvement projects.
- Adhere to compliance best practices, EHSS regulations and lean principles.
- Perform other work-related activities assigned by supervisor.
- Maintain compliance with all company policies and procedures
- Bachelor’s degree (or equivalent) in a relevant discipline with >2 years of related working experience.
- Advanced knowledge on lab systems and lab environment, data integrity and data management.
- Knowledge of statistical data analyses.
- Lean/BE experience
- Fluent communication in English
- Ability to be on-site for (at least) 3 days per week
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Didactical skills to effectively transfer information in a training environment.
- Proactive stakeholder management
This concerns a secondment contract via Yacht for 1 year. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefits package in line with your seniority and the seniority of the position. Salary between 2800 and 3400 gross per 4 week period.
The Leiden Quality Control (QC) Leiden department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site belonging to the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise.
The Release & Stability team leads and supports complex non-conformances investigations, initiates improvements to optimize the testing strategy and execution, and owns the Life Cycle Management activities for the commercial products tested at Leiden QC.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.