Location: Flanders,NJ, USA
Role Overview
The QC Investigation Specialist is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Major Responsibilities:
In this function you will be responsible to manage the QC related deviations and execute qualitative investigations in close collaboration with the analysts and the involved stakeholders according to the required procedures. Ensuring thorough root cause analysis is performed using the correct tools and proper CAPAs are defined in order to reduce non-conformances and deviations in the future. Different tasks are (but are not excluded to)
* Review/complete routine manufacturing and QC nonconformance/deviation investigations.
* Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
* Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories.
* Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders.
* Work closely with management to propose/execute improvements through the change management system.
* Drive continuous improvement.
* Ability to respond with a high degree of urgency to departmental and cross functional needs and requests.
* Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).
* Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
* Comply with all training requirements to perform duties on the job.
Education:
A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required and relevant years of experience within the pharmaceutical industry.
Experience:
A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Capabilities, Knowledge, and skills:
* Experience in a Quality Control setting is preferred.
* Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
* Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based
products is required.
* Knowledge of Good Tissue Practices is required.
* Detailed knowledge of CAR-T QC test methods and related equipment is preferred.
* Excellent written and oral communication skill are required.
* Candidates must be able to accommodate shift schedule. Shifts include routine weekend and
evening work as required by the manufacturing process.
* Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
* The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
* Comfortable with speaking and interacting with inspectors.
* Language(s): Dutch & English