Training Specialist Virginia
Posted on: September 16, 2023
Location - Variable, within 50 miles of any SOFIE facility
Department - Quality/ Compliance
Reports To - Quality Manager, Training
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
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
Assist in onboarding training and offboarding control of personnel
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
Provide OTJ training and execute the qualifications of
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
Effectively communicate with team members, trainers, and
Keep abreast of training trends, developments, and best
Assist with the closure and completion of corrective and preventive
actions, change controls, and exception documents that reference
Collaborate and strategize with the Operations' Training
Utilize Training/Learning Management System (LMS) software
Continuously seek to improve training and processes.
Other responsibilities as required.
Domestic travel up to 50
Bachelor's Degree in Science (chemistry, microbiology, or biology
2 years in a cGMP laboratory/ production environment including
Knowledge of USP, FDA, and CGMP regulations preferred.
Knowledge of how and ability to write, review, and revise SOPs
Superb track record in developing and executing successful training
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
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
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.
Keywords: SOFIE, Sterling , Training Specialist Virginia, Other , Ashburn, Virginia
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