Legend Biotech US

Legend Biotech US

Operations Gowning Trainer

Raritan, New Jersey, United States

Sponsorship not specifiedDetected 26 days ago
GMPCommunicationCollaborationGxP

About the role

  • This position is responsible for performing manufacturing gowning training and the execution of gowning training tasks within a CGMP environment.
  • This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Responsibilities

  • Support the Gowning Training Program responsible for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
  • Execute manufacturing gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation using appropriate gowning techniques.
  • Perform gowning training and execution that follows standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
  • Drive continuous improvement of gowning techniques and processes leveraging own observation as well as input of team members.
  • Support schedule adjustments to meet production and business needs.
  • Accurately complete documentation in SOP's, logbooks, GMP documents, and training events.
  • Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
  • Support the ongoing production schedule by:
  • Perform other duties as assigned.
  • develop professionally.

Requirements

  • Knowledge of Process Excellence Tools.
  • Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
  • 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 stop, and reach with hands and arms.
  • Ability to lift 25 lbs.
  • Work in a team based, cross-functional environment to complete production tasks required by shift schedule.

Benefits

  • Perform tasks on time in a manner consistent with quality systems, cGMP, and Learning Management System (LMS) requirements.

This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.