Training Specialist II

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs.  We are a growing organization with a bright future, and we are looking for motivated and experienced team members.  We offer a comprehensive benefits and a generous Paid Time Off package.  This role will initially be on site Monday through Friday, with potential for hybrid once training period is complete.  

The position is responsible for all actions of the ADDIE Instructional Systems Design model including performing needs analysis/assessments and designing, developing implementing, and evaluating training solutions. Manages and maintains the validated Quality Learning Management System (LMS) as subject matter expert and ensuring the application is inspection ready. This position is responsible for conducting group and individual training sessions, materials/media development and scheduling, and record keeping. Ensures continuous improvement in the training program. Works with departments to determine business needs and/or alignment with strategic goals, source/develop content, and format of training materials.  Works as a business partner to organize and present training sessions to groups or individuals in the areas of regulatory related processes such as SOPs, GXP, Occupational Health and Safety and leadership, plus job specific development trainings.  Participates in other quality systems activities such as internal audit, inspection preparation and change control as required.

• In partnership with business leadership, analyze business and performance needs, determining what solutions are required to address those needs
• Partner with leaders on projects that address performance and business goals and needs of the organization
• Facilitate classroom training including new hire and annual training and/or conduct structured on-the-job training in the work environment 
• Communicate effectively in visual, oral and written form
• Demonstrates effective presentation, facilitation and questions skills while in the classroom
• Uses media and technology to enhance the learning and performance
• Creates and manages an environment that fosters learning and performance 
• Conducts needs assessments and recommends appropriate design solutions and strategies
• Selects and uses various techniques for determining instructional content based on outcome of needs analysis/assessment
• Designs and develops instructional and non-instructional interventions/solutions
• Designs and develops learning assessment/evaluation strategies; prepares, analyzes and presents results
• Revises materials based on assessment/evaluation findings/outcomes
• Partners/collaborates with Subject Matter Experts to identify need, target audience and desired performance standards
• Plans and manages program design projects using a structured approach using a variety of tools including but not limited to a detailed project plan, Program Proposal/Business Case, Design Document, facilitating meetings, etc.
• Design curriculum and programs for designated department(s) to meet specific needs
• Work with functional management to design training including job specific tasks, SOP training, FDA cGMP, Health & Safety regulations, HR, leadership, interpersonal skills and general work skills as needed
• Develop qualifications/evaluations to ensure training effectiveness
• Actively support, participate and recommend continuous improvements to the training processes
• Creates User set ups, security roles, system setup, system maintenance, application specific evaluation and testing including executing system protocols for upgrades
• Provides LMS system user assistance and resolving Help Desk Tickets 
• Provides Training Guidance for the Change Control Process (i.e., Tech Assessments)
• Ensure course material, training records and databases are maintained in a cGMP & OSHA compliant manner
• Partners with team members in creating Storyboard’s/PPT Presentations that enhance learning program objectives, to ensure the narrative is engaging and aligned with our desired tone; suggests what information should be presented to employees
• Maintain records and prepare statistical reports to evaluate performance and progress of trainees
• Use Learning Management System (LMS) to monitor registrations and training completion
• Shares support of Learning Management System (LMS) administration and backup function
• Provide training records/reports for regulatory and customer audits
• Maintain effectiveness of the Quality System components relevant to this position
• Identify, evaluate, and manage risk to ensure product quality.  Communicate risk policies and processes throughout the organization.
• Other duties as assigned

Education or Equivalent: 

• Bachelor’s Degree or equivalent experience in a learning and development/training/communication/HR or other related field; Master’s degree preferred in Instructional Design or equivalent program, or equivalent experience

Experience:  

• 5 or more years of experience in training or education including facilitation, performance management, curriculum and instructional design (multi-media preferred)
• FDA or related regulatory work environment experience preferred
• Project management leadership required

Knowledge/Skills Requirements:  

• Well-developed planning, organizational and project management skills; ability to lead projects and meetings
• Strong presentation, instruction and facilitation skills
• Proven working experience in instructional design and with instructional technology
• Excellent knowledge of learning theories and instructional design models
• Ability to create engaging learning activities and compelling course content that enhances memory retention and transfer of knowledge
• Clearly set the criteria used to judge learner’s performance and develop assessment instruments to measure performance
• Excellent documentation skills
• A full complement of business computer literacy skills (e.g., word processing, desktop publishing, presentation, spreadsheets, database software, etc.)
• Strong problem solving and analytical skills
• Must possess appropriate verbal, written, and interpersonal communication skills allowing direct interaction with internal Managers and Sr. Management
• Works well in a team environment
• Well organized and detail and multi-task oriented
• Works well under pressure and able to prioritize workloads to meet deadlines
• Review reports, etc. for accuracy and logic
• Should be familiar with cGMP and safe work practices
• Maintain good records, ensure quick access to filed records, and ability to retrieve information in a timely manner 
• Be knowledgeable; bring experience to the organization; learn new skills; collect new information; demonstrate a willingness to share skills and information with others
• Demonstrate a bias toward action; be willing to take a position, and assert influence to drive improvement; foster teamwork to get results 
• Demonstrate initiative; develop ideas, and collect them from others
• Demonstrated ability to read, write, and speak clear English

Physical Requirements:  

• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening
• Occasional bending, carrying, stooping
• Occasional lifting and/or moving up to 20 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.