Location: Raritan, NJ
Company: Legend Biotech USA
This individual will partner with system functionality owners in collaboration with management in Operations to support personalized cell therapy production through safe and compliant operations according to c GMP requirements. The role will require technical experience, effective communication, leadership, coordination, and collaboration across relevant cross functional groups to enable robust systems training program for advancement of Raritan CAR-T Operators.
Key Responsibilities Leads, coaches and delivers a holistic, effective systems training program for Operations (Manufacturing) that support daily clinical and commercial production supply of a CAR-T product. Manages, plans, coordinates,
prepares and performs Instructor Led Training in areas of (but not limited to) to MES and S4. Manages the retention and archival of training related documents.
Collaborates and stays connected with System Subject Matter Experts on updates and changes to systems. Conducts knowledge and skill checks and independent performance qualifications for Operations. Works on training improvement projects that make a positive impact on the systems training program. Assists with writing or revising SOPs/Work Instructions, knowledge and skills backssments. Performs training backssments for new and updated procedures and implementations. Collaborates with Process Engineering and Technical Support on
implementation projects that may impact system functionalities.
Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for Operations and other support areas. Optimizes the effectiveness and efficiency of systems training program in delivery of personnel who use systems day to day. Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution. Serve as back up to subject matter expert for Compliance & Training systems. Elevated access level in LMS to capture training compliance in real-time and assign training as needed.
Supports the maintenance and reporting of quality training metrics. Requirements A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required. A minimum of 5 years relevant work experience is required. Candidate must have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems. Knowledge of c GMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs. LMS experience Advanced computer skills and practical knowledge of MS Office Suite, Share Point, and other related systems. Good verbal and written communication skills Excellent organizational skills. Ability to effectively prioritize and execute tasks in a fast-paced environment. Works well in a team-oriented, collaborative environment. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Proactive and continuous improvement oriented. Ability to lead with influence. c GMP manufacturing. Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members. Strong analytical, problem solving and critical thinking skills. Project management. Change management. Transparent, Passionate, Fearless and Accountable. #Li-Onsite#Li-JK2
Training Jobs are specialized programs designed to enhance an individual's skills and knowledge in a specific field or profession. These jobs are often created within companies or educational institutions to prepare participants for particular roles through hands-on experience and expert instruction. Key features of Training Jobs include structured learning curriculum, mentorship from industry professionals, and the potential for job placement upon successful completion of the program. They serve as an important bridge between theoretical learning and practical application, often focusing on emerging technologies or high-demand sectors, providing trainees with both the competence and confidence to excel in their chosen career paths.
all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity! Position Overview: This position is responsible for the accurate and timely processing of all training requests and successful updates to the electronic Gx P Learning Management System (LMS).
Provide technical support to the business as required for use of the LMS. Ability to clearly communicate both verbally and in written form. Responsibilities: Manage and assign training curriculums for site personnel in LMS. Administers the LMS and Training Management request system (Service Now); 60% of daily activities are performed in an electronic system to address training related requests. Provides
support for miscellaneous requests. Provide LMS troubleshooting. Recognizes and resolves training discrepancies. Reviews documents for Training backssments via the e DMS and provide support to the Records Management team.
Responsible for providing training metrics for multiple levels of the organization as well as audit support. Files all hard copy training documentation and provides general administrative support as required. Contributes to projects and goals within the work group. Performs other tasks as assigned. Required Qualifications: Must have basic c GMP and Quality knowledge. Intermediate to advanced skills navigating an electronic Learning Management System (LMS) and electronic
Document Management System (e DMS). Prior experience in Success Factors LMS, preferred.
Functional responsibilities include support for the sites development of GMP training. Intermediate to advanced skills in design, development, and implementation of training materials in multiple media's. Must be able to properly and clearly communicate verbally as well as via e-mails on a routine basis. Must be action-oriented, self-directed worker and customer-focused. Skilled in decision-making, problem solving, planning and organization. Requires minimal direction, completes routine tasks with little or no supervision. Confident in making decisions for minor issues and recognizes quality issues while working with a sense of urgency.
Follows established procedures and performs work as assigned. Builds relationships internally with cross functional teams as well as providing systems support. Able to effectively multi-task and work independently. Minimum of 2 years of experience in the medical or related industry. Experience in the Success Factors, Service Now and / or Veeva GMP Systems beneficial. Must be familiar with GMP requirements, preferably as part of a QA organization / department. Experience as a GMP Qualified Trainer for Adult Learners would be a positive attribute.
Beginner to advanced experience in creation of computer based training modules (e. g. Captivate, Articulate, Storyline, etc. ), would be valuable. If hired, you will enjoy the following Eclaro Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro If interested, you may contact: Moneth Rojas xyz X@ (516) 386-xyz X Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, interaction, interactionual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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Training Jobs refer to employment opportunities specifically designed to provide individuals with the skills and experience needed for a particular job or industry. These roles typically combine hands-on training with theoretical learning, offering participants the chance to develop practical competencies while being guided by experienced professionals. Key features of Training Jobs include structured learning plans, mentorship, performance evaluations, and often the potential for full-time employment upon successful completion. They are beneficial for newcomers to the workforce or those looking to switch careers, as they facilitate growth and learning within a supportive work environment.
Training Jobs are specialized roles aimed at enhancing the skills and knowledge of employees within an organization. These positions focus on designing, delivering, and evaluating effective training programs tailored to the specific requirements of a company's workforce. Key features of Training Jobs include a passion for teaching, strong communication abilities, and a deep understanding of educational best practices and learning methodologies. Training Jobs play a crucial role in workforce development, ensuring that employees remain proficient and up-to-date with industry standards and new technologies.
