QA Specialist - Shopfloor

We are looking for the best candidate for the QA Specialist – Shopfloor position, to be based in Sassenheim.

QA-AT supports the clinical and commercial manufacturing of Lentivirus, an important component for Johnson and Johnson’s CAR-T therapy.

The Specialist QA acts as a quality expert and ensures quality oversight of our AT products and processes. Plays a crucial role in ensuring that our manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. The Specialist QA works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

The QA specialist will focus primarily on shopfloor activities including AQL execution. AQL (Acceptable Quality Level) is applied as a risk mitigation to the visual inspection process by random re-inspection of a statistically relevant sample size. Thereby concluding on the quality of the original inspection process and overall batch acceptability. Additionally, the QA specialist will perform quality oversight activities throughout the different manufacturing stages , ensuring that the tasks being performed are in compliance with established best practices, guidelines and procedures.

As a QA Specialist, you will:

• Implement and execute AQL and related visual inspection tasks performed by the QA unit according to applicable standards and company procedures.
• Execute quality oversight activities in manufacturing and other areas, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.
• During execution of AQL/shopfloor activities, record and maintain accurate GMP documentation and report non conformances or deviations observed.
• Perform/review line clearance activities between batch / product campaigns.
• Reviews and approves routine GMP documentation for all components of the Quality system.
• Reviews and approves release documentation for LVV, including QA review of electronic batch records and related documentation.
• Reviews and approves Maintenance notifications and work orders (NI-NS) and SAP-PM Master Data Changes (N2, N5 and N6), as well as the approval of Maintenance and Calibration related documents (as needed).
• Promotes improvement initiatives to set up , standardize and lean out QA processes within the team.
• Provides Site support for local or global projects as an SME or QA core team member.
• Engages in internal audits and inspections as an SME or in support functions.
• Escalates serious quality, compliance and /or GMP incidents to management.

Qualifications/Requirements:

• Degree in science related subject and /or business-related area with 2-4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. QA experience preferred.
• Experience in AQL / visual inspection and QA shopfloor activities preferred.
• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.
• Knowledge of current Quality Management principles, GMP and Quality Systems, Pharma regulations.
• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.
• Problem solving, analytical thinking and decision making capabilities.
• Demonstrated proficiency in English both in word and in writing. Dutch is a pre but not mandatory.
  

The role is expected to be able to support a Early/Late shift schedule according to manufacturing planning (e.g. including evening and weekend schedule).

Early will be from 07:00 to 15:30 and Late shift from 15:00 to 23:30