Training Specialist I

SOFIE; Totowa (NJ); On-site; USD 75,000 - 85,000; Full time

Job summary

SOFIE is seeking a Training Specialist to support quality, manufacturing, and operations across the network by developing, delivering, and evaluating training programs for employees in New Jersey.

The role focuses on assessing training needs, creating curricula, onboarding and offboarding training, and collaborating with QA, SA, and RCM teams while traveling up to 50% to SOFIE sites.

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.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, customers and partners required.
• Proficiency in MS Office applications and related business tools required.

Responsibilities

• Learn and understand SOFIE network operations, quality, and decision‑making processes.
• Identify and assess training needs through job analysis and consultation with leadership.
• Develop individualized and group training programs addressing SOFIE network needs.
• Deliver training courses and workshops (in person, train the trainer, virtual).
• Assist in onboarding training and offboarding control of personnel and processes.
• Work with RCM to establish new and partner product training programs.
• Work with SA to create a strong aseptic training program.
• Work with QA to ensure CGMP requirements are met.
• Create OTJ training curriculums and qualifications for QC testing and product manufacturing.
• Travel to SOFIE network sites for hands‑on training (up to 50%).
• Create printed and instructional materials and administer post‑training tests.

Skills

Training development

cGMP knowledge

Analytical skills

SOP writing

MS Office

Communication

Multitasking

Problem solving

Education

Bachelor’s Degree in Science (chemistry, microbiology, or biology preferred)

Tools

LMS software

Job description

Overview

The Training Specialist supports quality, manufacturing, and operational initiatives for the SOFIE network by (1) assisting in developing, facilitating, and supervising training programs for employees. (2) assessing the needs of the SOFIE network, implementing training, assisting in developing plans, and facilitating a variety of training initiatives and programs that enhance the effectiveness of the SOFIE workforce.

• 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.
• Assist in creating On-the-Job (OTJ) training curriculums.
• Establish qualifications for Quality Control (QC) testing, product manufacturing, etc.
• Provide OTJ training and execute the qualifications of personnel.
• Travel to SOFIE network sites to complete hands‑on training.
• Assist in creating printed and 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 Operations’ Training Manager
• Continuously seek to improve training and processes.
• Other responsibilities as required.
• Domestic travel up to 50

Department | Quality/ Compliance
Reports To | Quality Manager, Training
Compensation | $75,000-$85,000

Overview

The Training Specialist supports quality, manufacturing, and operational initiatives for the SOFIE network by (1) assisting in developing, facilitating, and supervising training programs for employees. (2) assessing the needs of the SOFIE network, implementing training, assisting in developing plans, and facilitating a variety of training initiatives and programs that enhance the effectiveness of the SOFIE workforce.

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.
• Assist in creating On-the-Job (OTJ) training curriculums.
• Establish qualifications for Quality Control (QC) testing, product manufacturing, etc.
• Provide OTJ training and execute the qualifications of personnel.
• Travel to SOFIE network sites to complete hands‑on training.
• Assist in creating printed and 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 Operations’ Training Manager
• Utilize Training/Learning Management System (LMS) software platforms
• Continuously seek to improve training and processes.
• Other responsibilities as required.
• Domestic travel up to 50

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.
• 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 candidates should be innovative, strong decision‑makers, and outstanding facilitator of learning and change.