CGMP Training Specialist I — Onboarding & OTJ Programs

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

Job summary

SOFIE seeks a Training Specialist to support quality, manufacturing, and operational initiatives by developing, facilitating, and supervising employee training programs. You will assess needs across the network and implement training initiatives that enhance workforce effectiveness.

Responsibilities include onboarding/offboarding training, OTJ curriculum development, QA collaboration, and creating tests to measure program impact. Travel up to 50% across SOFIE sites.

Qualifications

• Bachelor’s degree in science (chemistry, microbiology or biology preferred).
• Minimum 2 years in a cGMP laboratory/production environment with training experience.
• Knowledge of USP, FDA, and CGMP regulations preferred.
• Ability to read, write, and revise SOPs.
• Proven track record of developing and executing training programs.
• Strong analytical, organizational, and communication skills.

Responsibilities

• Learn SOFIE network operations and CGMP requirements.
• Identify training needs through job analyses and knowledge gaps.
• Develop and deliver individualized and group training programs.
• Create OTJ training curriculums and assess qualifications.
• Travel to SOFIE sites to provide hands-on training (up to 50%).
• Create printed/instructional materials and tests to measure effectiveness.
• Collaborate with QA, SA, RCM, and Operations Training Manager to improve processes.

Skills

Analytical skills

Communication

Reading regulations

Time management

Problem solving

Learning facilitation

Strategic thinking

Detail oriented

Multitasking

Education

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

Tools

MS Office

Job description

SOFIE seeks a Training Specialist to support quality, manufacturing, and operational initiatives by developing, facilitating, and supervising employee training programs. You will assess needs across the network and implement training initiatives that enhance workforce effectiveness.

Responsibilities include onboarding/offboarding training, OTJ curriculum development, QA collaboration, and creating tests to measure program impact. Travel up to 50% across SOFIE sites.