Training Specialist
Not Disclosed•Full-TimeOn-site
location_onColumbia Place, Dutch Neck, West Windsor, Mercer County, New Jersey, 08550, United States
About the Role
The Training Specialist serves as a strategic partner to the Quality, Compliance, and Manufacturing teams within the SOFIE network. This role exists to bridge the gap between operational needs and workforce capability, ensuring that every employee possesses the foundational knowledge and practical skills required to maintain the highest standards of quality and safety.
In this position, you will drive the SOFIE philosophy through all development activities. Your day-to-day involves assessing organizational training needs through job analysis and consultation with leadership, then translating those insights into effective individualized and group programs. You will facilitate a variety of training initiatives—including "train the trainer" sessions, face-to-face workshops, and virtual courses—while collaborating closely with the Radiopharmaceutical Contract Manufacturing (RCM), Sterility Assurance (SA), and Quality Assurance (QA) teams to build robust training ecosystems.
Beyond content creation, you will be responsible for the full lifecycle of training execution: from developing On-the-Job (OTJ) curriculums and instructional materials to administering assessments that measure effectiveness. You will also support onboarding and offboarding controls, assist in closing corrective actions, and utilize Learning Management System (LMS) platforms to track progress. This role requires a blend of analytical rigor and creative facilitation to continuously improve processes and adapt to a fast-paced environment.
Work location
Work model: On-site
Columbia Place, Dutch Neck, West Windsor, Mercer County, New Jersey, 08550, United States
West Windsor, New Jersey
Key Responsibilities
- check_circleAssess training needs through job analysis and consultation with leadership
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Similar Job Opportunities
Skills, education and keywords
Skills: CGMPR, Usp, Fda, Sop, LMS, MS Office.
Education: Bachelor's Degree in Science required.
Frequently asked questions about Training Specialist at SOFIE
What does a Training Specialist at SOFIE do?expand_more
A Training Specialist at SOFIE is responsible for the following: Assess training needs through job analysis and consultation with leadership; Create and administer tests to determine the effectiveness of training strategies; Travel to network sites to complete hands-on training and execute personnel qualifications; and Assist with the closure of corrective actions, change controls, and exception documents.
What are the requirements for this Training Specialist role?expand_more
To qualify for the Training Specialist at SOFIE position, applicants should have: 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; Ability to write, review, and revise SOPs required; Ability to read, analyze, and interpret governmental regulations, professional journals, or technical procedures required; and Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.
Where is the Training Specialist role at SOFIE located?expand_more
Training Specialist at SOFIE is based in Columbia Place, Dutch Neck, West Windsor, Mercer County, New Jersey, 08550, United States. This is a on-site role.