Training Specialist

Sofie Co.•Dallas, TX

6d•$75,000 - $85,000

About The Position

The Training Specialist supports quality, manufacturing, and operational initiatives across the SOFIE network by helping develop, facilitate, and supervise employee training programs. The role assesses organizational training needs, implements training, helps develop training plans, and facilitates initiatives that improve workforce effectiveness. The position is in the Quality/Compliance department and reports to the Quality Manager, Training. The work location is variable within 50 miles of any SOFIE facility, and the role involves domestic travel to SOFIE network sites for hands-on training, up to 50% of the time. The compensation range is $75,000–$85,000.

Requirements

Bachelor's degree in Science.
Two years of experience in a cGMP laboratory or production environment, including performing training.
Knowledge of how to write, review, and revise SOPs.
Ability to read, analyze, and interpret governmental regulations, professional journals, and technical procedures.
Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
Ability to present information effectively, deliver training, and respond to questions from groups of managers, clients, customers, and the general public.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to solve problems and handle issues.
Proficiency in MS Office applications and related business and communications tools.
Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors and partners.
Strong analytical, organizational, and time-management skills, with the ability to multitask and adapt in a fast-paced environment.
Critical thinking and innovative problem-solving skills.
Strategic and creative mindset.
Meticulous attention to detail.

Nice To Haves

Bachelor's degree in chemistry, microbiology, or biology.
Knowledge of USP, FDA, and CGMP regulations.
A strong track record of developing and executing successful training programs.
Innovative approach, strong decision-making, and outstanding facilitation of learning and change.

Responsibilities

Learn and understand SOFIE network operations, quality, and decision-making processes.
Identify and assess organizational training needs through job analysis, knowledge-gap assessment, operational analysis, and consultation with network leadership.
Develop individualized and group training programs that address SOFIE network needs.
Deliver training courses and workshops through train-the-trainer, face-to-face, and virtual methods.
Assist with onboarding training and offboarding controls for personnel and processes.
Work with Radiopharmaceutical Contract Manufacturing (RCM) to establish new and partner-product training programs.
Work with the Sterility Assurance (SA) team to create an aseptic training program.
Work with the Quality Assurance (QA) team to provide employees with a strong foundation in CGMP requirements.
Assist in creating On-the-Job (OTJ) training curricula.
Establish qualifications for Quality Control testing, product manufacturing, and related work.
Provide OTJ training and execute personnel qualifications.
Travel to SOFIE network sites to conduct hands-on training.
Assist in creating printed and instructional training materials.
Create and administer post-training tests to assess the effectiveness of training strategies.
Promote SOFIE values and philosophy through training and development activities.
Communicate effectively with team members, trainers, and management.
Stay current with training trends, developments, and best practices.
Assist with closing and completing corrective and preventive actions, change controls, and exception documents that reference training.
Collaborate and strategize with the Operations Training Manager.
Use Training/Learning Management System (LMS) software platforms.
Continuously seek to improve training and processes.
Perform other responsibilities as required.