Senior Training Specialist at SOFIE

Job Description | Senior Training Specialist
Title | Senior Training Specialist
Location | Variable, within 50 miles of any SOFIE facility (Corporate (CO1))
Department | Quality & Compliance
Reports To | Associate Director, Training

Overview
The Senior Training Specialist supports quality, manufacturing, and operational initiatives for the SOFIE network by
(1) leading the development, facilitating, and supervising training programs for employees. (2) Assessing the needs
of the SOFIE network, implementing training, developing plans, and facilitating a variety of training initiatives and
programs that enhance the effectiveness of the SOFIE workforce. (3) Collaborate with teams and SME’s to ensure
compliance with industry standards.

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) team to establish new and partner product training programs.
• Work with the RCM group to become a SME for new and existing products.
• Work with the Sterility Assurance (SA) team to strengthen the aseptic training program.
• Work with the Quality Assurance (QA) team to ensure all employees have a strong foundation of CGMP requirements.
• Lead the creation of On-the-Job (OTJ) training curriculums and working with SMEs as applicable.
• Establish qualifications for Quality Control (QC) testing, product manufacturing, etc.
• Provide OTJ training and execute qualifications of personnel.
• Travel to SOFIE network sites to complete hands-on training.
• Assist in creating instructional materials to be distributed during training.
• 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.
• Assist with the closure and completion of corrective and preventive actions, change controls, and exception documents that reference training.
• Collaborate and strategize with the Pharmacy Excellence Manager
• Utilize Training/Learning Management System (LMS) software platforms
• Continuously seek to improve training delivery and content and processes.
• Assist in creating instructional materials, SOPs, and guides for LIMS, Production software, QC tools, electronic documentation management software (e.g., TrackWwise) and LMS (e.g. Absorb) to support consistent and efficient system usage.
• Other responsibilities as required.
• Domestic travel up to 40%

Qualifications
• Bachelor’s Degree in a Science (chemistry, microbiology, or biology preferred)
• 5 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 and quality documentation required. Superb track record in developing and executing successful training programs preferred.
• Have 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.
• Top candidate will be innovative, strong decision-maker and outstanding facilitator of learning and change.