Qc Analyst Car-t Biotech

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Non-Standard Job Sub Function: Workday Associate B Job Category: Non-Standard All Job Posting Locations: Beerse, Antwerp, Belgium About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The QC Analyst, CAR-T Biotech is responsible for performing quality control testing related to final drug product release, stability testing, and incoming lentiviral batch identification testing. The role ensures that all laboratory activities are executed in compliance with GMP regulations, company procedures, and quality standards. As a key member of the QC team, the analyst supports laboratory operations, data integrity, audit readiness, investigations, documentation, equipment maintenance, and continuous improvement initiatives while contributing to a safe and compliant working environment.

Key Responsibilities
:
- Perform analytical testing for final drug product release, stability studies, and incoming lentiviral batch identification in accordance with GMP requirements and approved procedures.
- Conduct peer review of laboratory data to ensure accuracy, compliance, and data integrity.
- Author, revise, and maintain SOPs, Work Instructions (WIs), and protocols as a QC Subject Matter Expert (SME).
- Support laboratory investigations, deviations, CAPAs, equipment qualification, calibration, and maintenance activities.
- Participate in internal and external audits, inspection readiness activities, laboratory meetings, and cross-functional collaboration forums.
- Deliver training within areas of expertise and promote a safe, compliant, and organized laboratory environment, including adherence to SHE (Safety, Health & Environment) standards. Requirements:
- Bachelor's degree in a Scientific discipline or a related field.
- Minimum of 2 years of experience in a cGMP-compliant Quality Control laboratory or similar regulated environment preferred.
- Experience with cellular and/or molecular analytical techniques such as qPCR, Flow Cytometry, and Potency Assays; CAR-T experience is highly desirable.
- Strong understanding of biological and biochemical analytical testing, with knowledge of QC laboratory technologies and preferably compendial requirements (USP, EP, JP).
- Excellent written and verbal communication skills in English; Dutch language skills are an advantage.
- Flexibility to work future Early and Late Shift schedules may be required. Here’s what you can expect:
- Application review:We’ll carefully review your CV to see how your skills and experience align with the role.
- Getting to know you:If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
- Staying informed:We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step. Required Skills: Preferred Skills: The anticipated base pay range for this position is: €0,00
- €0,00 Benefits: