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