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Johnson & Johnson

NL - Release & Stability QC Coordinator

Posted Oct 18, 2021
Job ID: JJJP00008081
Location
Leiden
Duration
11 months, 4 weeks
(Dec 1, 2021 - Dec 1, 2022)
Hours/week
40 hrs/week
Payrate range
Unknown

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.


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. All test laboratories are supported by the Release & Stability team, which is integrated by product E2E QC owners who lead and coordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders (e.g. DPDS, PQM, VPAD, VCM, CMOs, EQ) and Leiden QC. 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.

Currently the Release & Stability team consists of 12 people and due to expansion of work load we are looking for new employees. 
We have positions open for junior, medior and senior profiles!

 


Tasks and Responsibilities:

  • Fully owns end-to-end product testing process within Leiden QC with some support.
  • Coordinates 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.
  • Coordinates the stability testing of JSC large molecule products according to local procedures and agreed timelines.
  • Acting as subject matter expert on release and stability processes and has a leading role during the GMP inspections.
  • Participates in meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience.
  • Responsible to coordinate all data requests provided by various stakeholders (e.g. RA; Health Authority; DPDS ) and has 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.
  • Provide input for the YBPR and APR requests.
  • Leads and drives 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.

 

Additional tasks and Responsibilities for medior and senior profiles:

  • Trains and mentors colleagues in expertise area.
  • Proactively shares knowledge with team and other sites and functions to drive improvement and alignment.
  • Is able to influence strategy of expertise area.
  • 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.
     

 

Job interaction areas:

  • Internal: functional departments within the Quality organization, Value Chain Teams, regulatory compliance group, R&D (DPDS, VPAD), Product Quality Management PQM), External Quality, Quality Assurance (QA), Business Units, manufacturing sites within JSC, Global Planning.
  • External: contract labs, CMOs
     


Minimum Qualification:

  • Bachelor’s degree (or equivalent) in a relevant discipline with related working experience.
  • Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
  • Fluency in English.
  • Didactical skills to effectively transfer information in a training environment. 
    Advanced knowledge on lab systems and lab environment, data integrity and data management. 
  • Knowledge of statistical data analyses.
  • Lean/BE experience.
  • Proactive stakeholder management.

 

Additional qualification for medior and senior profiles:

  • Develops training material.
  • Acknowledged expert on lab systems and lab environment, data integrity and data management. 
  • Engages heavily in stakeholder management regarding projects, testing risks, successes and delays.
  • Preferred: Experience in project management and GMP experience.


 

EXTRA INFORMATION:

  • You will work on-site in Leiden. Currently 3 days remote but this will change in the future.
  • 40 hours, 32 hours also possible.
  • This is a full-time position for 1 year. (Extension possible, but not guaranteed.)
  • This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).

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