QA Shop Floor Specialist III

Overview

Legend Biotech is seeking a QA Shop Floor Specialist III as part of the Quality Operations team based in Raritan, New Jersey
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The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Schedule:

Wed-Sat, 2nd Shift

• Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.
• Support manufacturing activities for cGMP compliance through spot checks/internal audits.
• Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.
• Review of all documentation, in accordance with Good Documentation Practices (GDP).
• Review, revise, or draft Standard Operating Procedures (SOPs).
• Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs to support manufacturing to ensure sterility of the product/process is not compromised.
• Support batch review & material release in SAP for In-house reagents.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Support Investigations team by providing quality and compliance input for continuous improvement and remediations.
• Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.
• Utilize multiple electronic quality systems, batch records and SAP.
• Work in a team-based, cross-functional environment to complete tasks required to meet business objectives.
• Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas.
• Provide QA shop floor support for extended periods of time.
• Responsibilities will include but not limited to tasks mentioned above.
• Support regulatory inspections and audits as needed.
• Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

The anticipated base pay range is: $75,972 USD - $99,713 USD.

• Bachelors degree required in Life Sciences or Engineering.
• 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience.
• Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy.
• Experience with quality support in clinical manufacture is preferred.
• Flexible to work on weekends, as needed.
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms.
• Ability to lift 20 lbs.
• Report to work on-time.
• Duties are required to be performed on-site at manufacturing facility.
• Perform other duties as assigned.
• Attend departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate positive team-oriented approach in the daily execution of procedures.
• Promote and work within a team environment.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Support and contribute to projects.
• Assist in troubleshooting issues related to manufacturing.
• Technical knowledge within functional units.
• Demonstrate an understanding of the process to properly perform the assigned tasks.
• Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (E ), and quality systems.
• Utilizes tools within MS Office and other systems to improve business effectiveness.
• Read and interpret…