Specialist QC Raw Materials

Janssen Biologics is currently looking for a 1 year ad interim QC-Raw Material (RM) Specialist 2 LCM within our Quality Control department. The successful candidate needs to understand the QC testing environment and has relevant educational background. The candidate is responsible for supporting timely execution of QC RM projects, including but not limited to: lifecycle management of analytical methods, vendor driven-, compendial-, and internal changes.

The Leiden Quality Control department is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and advanced therapies manufacturing site that is part of the Janssen Supply Chain. The Leiden QC department is responsible for raw material, in-process and release testing for products manufactured at the site.

The Leiden QC-RM Team has a unique global responsibility and exposure by being the RM Global SMEs for large molecule Biotherapeutics and Advanced Therapies products within QC laboratories and by partnering with multiple sites and teams both internally and externally to perform RM testing for multiple sites.

You will be responsible for:

• Supporting QC-RM (project) activities in relation to lifecycle management of analytical methods, (compendial) raw material testing, and/or technology transfers.
• Initiation and owning change controls for internal projects and make sure actions and the change itself are closed in a timely manner.
• Assessing changes regarding supplier change notifications.
• Lead deviation and non-conformance investigations related to QC Raw Materials and ensure timely closure.
• Participates in/or lead meetings with various local/global/internal/external stakeholders.
• Creates, reviews, and approves related documentation.

Qualifications/Requirements:

• Bachelor’s degree (or equivalent) in a relevant discipline, with 3–5 years of experience in a GMP-regulated environment.
• Working knowledge of raw materials testing and QC processes.
• Experience using systems such as Comet, eLIMS, and SAP. Proven experience with owning change controls is a pre.
• Strong critical thinking and verbal and written communication skills, including ability to effectively communicate with stakeholders
• Proactive, pragmatic with excellent analytical and problem-solving skills.
• Work independently but is also a team player.

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy

Hybrid work