Training Specialist

Essential Duties And Responsibilities

• Learn and understand SOFIE network operations, quality, and decision-making processes.
• Identify and assess the training needs of the organization through job analysis, knowledge gaps, operational analysis, and consultation with other SOFIE network leadership.
• Develop individualized and group training programs that address specific SOFIE network needs.
• Deliver training courses and workshops, utilizing a variety of methods (train the trainer, face to face, and virtual courses).
• Assist in onboarding training and offboarding control of personnel and processes.
• Work with the Radiopharmaceutical Contract Manufacturing (RCM) to establish new and partner product training programs.
• Work with the Sterility Assurance (SA) team to create a strong aseptic training program.
• Work with the Quality Assurance (QA) team to ensure all employees have a strong foundation of CGMP requirements.
• Create and administer tests after the completion of training courses to determine the effectiveness of training strategies.
• Drive SOFIE values and philosophy through all training and development activities.
• Effectively communicate with team members, trainers, and management.
• Keep abreast of training trends, developments, and best practices.
• Aid in the closure and completion of corrective and preventive actions, change controls, and exception documents that reference training.
• Collaborate and strategize with the Operations’ Training Manager.
• Utilize Training/Learning Management System (LMS) software platforms.
• Continuously seek to improve training and processes.

Qualifications

• Bachelor’s Degree in Science (chemistry, microbiology, or biology preferred).
• 2 years in a cGMP laboratory/ production environment including performing training.
• Knowledge of USP, FDA, and CGMP regulations preferred.
• Knowledge of how and ability to write, review, and revise SOPs required.
• Superb track record in developing and executing successful training programs preferred.
• Excellent analytical skills with the ability to multitask and adapt in a fast-paced environment.
• Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
• Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Ability to solve problems and handle issues required.
• Proficiency in MS Office applications and related business and communications tools required.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors and partners required.
• Critical thinker with innovative problem-solving skills.
• Strong organizational and time management skills.
• Strategic and creative mindset.
• Meticulous attention to detail.