Training Specialist

Role Summary

Location: Swiftwater, PA. The Training Specialist is responsible for increasing productivity by teaching new skills and knowledge to employees, using adult learning theory through classroom training, lab environments, and exercises to enhance learning. This role establishes and maintains the GMP training program to ensure compliance with quality systems and current Good Manufacturing Practices (cGMPs) in support of the biologics industry. Training employees on GMP, GXP, aseptic technique, gowning and related topics at the Swiftwater site to ensure regulatory readiness.

Responsibilities

• Developing and implementing annual training programs to ensure compliance with GMP and company standards
• Collaborating with department heads to identify training needs and developing customized training plans
• Supporting the managers in the establishment of the curricula for the different areas
• Developing training materials with the support of the relevant subject matter expert to address the training needs and plans
• Conducting training sessions for new hires and existing employees on specific topics
• Monitoring the completion of the training plan to identify risks and weaknesses
• Evaluating training effectiveness through assessments, feedback, and performance metrics
• Support Subject Matter Expert in updating training materials to reflect changes in regulations, procedures and best practices
• Leading continuous improvement initiatives to enhance training material and processes
• Providing support during regulatory inspections and audits by presenting training records and training process and material
• Training topics for New Employee Onboarding (NEO) and Aseptic related trainings (EM, Aseptic Technique, Gowning, Advanced Aseptic Technique, etc.)
• Understand adult learning theory and applying this to classroom training
• Train in classroom as well as lab environments
• Facilitate the transfer of learning to adults through engaging tools and instruction
• Provide trainings as needed to meet site and regulatory requirements
• Developing and implementing annual training programs to ensure compliance with GMP and company standards

Qualifications

• Required: This position supports 1st shift. However, the Training Specialist must be flexible to deliver training to the 2nd and 3rd shifts trainees, as needed for business continuity
• Required: 3-5 years of experience in Pharmaceutical/FDA-regulated environment
• Required: Experience and knowledge in Aseptic/Gowning/Environmental Monitoring/GMP, etc. processes required for Class A/B and C/D rooms
• Required: Experience in evaluating and measurement of employee training and transfer of learning
• Required: Ability to embed Adult Learning Theory in training and education
• Required: Trainer must be or be able to become Aseptic Gown trained and Qualified to train others and must maintain this status yearly
• Required: High school diploma or equivalent
• Preferred: BA/BS degree in the Scientific field or Training
• Preferred: Sterility Assurance (SA) knowledge
• Preferred: Aseptic gown qualified
• Preferred: Aseptic Technique qualified
• Preferred: Advanced Aseptic Technique qualified
• Preferred: EM qualified
• Preferred: Qualified Trainer

Skills

• Ability to create effective training programs and materials that meet the needs of the organization and comply with regulatory standards
• Proficiency in evaluating training effectiveness through data analysis, assessments, and feedback to continuously improve training programs
• Strong understanding of regulatory requirements and the ability to ensure training programs align with these standards
• Expertise in planning, organizing, and managing training projects, including setting timelines, allocating resources, and monitoring progress
• Excellent verbal and written communication skills, with the ability to effectively convey information, collaborate with various departments, and present training outcomes to senior management

Education

• High school diploma or equivalent required.