Experienced Specialist QA AT

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

We are seeking a highly motivated individual to join our QA Advanced Therapies team, located in Sassenheim, the Netherlands. QA-AT supports the clinical and commercial manufacturing of Lentivirus, an important component for Johnson and Johnson’s CAR-T therapy.

The Experienced 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 Experienced Specialist QA works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

Essential Job duties and Responsibilities

• Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition.  

• Ensures that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.

• Escalates serious quality, compliance and /or GMP incidents to management and support (Global) escalation of issues, which have potential impact on the delivery of products to patients.

• Participates in Hazard / Risk assessments to ensure compliance or quality is not jeopardized. 

• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, Qualifications etc.) for site colleagues to ensure compliance to cGMP and company training requirements. 

• Provides review and approval of various document changes and change controls.

• Executes Quality Aseptic Processing Oversight activities, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.

• 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.

• On a rotation basis is available for beeper duty on out office hours and if quality oversight is needed during manufacturing (e.g. QAPOP)

Experience and Skills

• Degree in science related subject and /or business-related area with more 4-6 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. Experience in a QA role for at least 2-4 years.

• Proven experience working with quality systems, ensuring compliance with industry standards, GMP principles and regulatory requirements.

• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.

• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended. 

• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.

• Problem solving, analytical thinking and decision making capabilities.

• Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude.

• Demonstrated proficiency in English both verbal and in writing. Dutch is a pre but not mandatory.