Training Specialist

We're Hiring : Training Specialist!

We are seeking a dynamic and experienced Training Specialist to design, develop, and deliver comprehensive training programs that enhance employee skills and drive organizational success. The ideal candidate will have a passion for learning and development, strong facilitation skills, and the ability to create engaging training content that meets diverse learning needs.

Location : Philadelphia, PA

Work Mode : Work From Office

Role : Training Specialist

Position Summary :

The Training Specialist I will be a trainer for the autologous cell therapy manufacturing program. A background in cell culture, aseptic technique, aseptic gowning and qualification, and ISO Class 5 cleanroom operations is required.

Essential Functions and Responsibilities :

• Develops a basic understanding of the current cell therapy manufacturing process and equipment utilized during processing, as this role is viewed as a subject matter expert (SME) within this specific area.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Presents and delivers content to manufacturing technicians.
• Assists with the creation, review, and improvement of designated training scripts; On-the-Job and Instructor-Led Trainings (OJTs and ILTs).
• Supports management with the alignment of manufacturing processes with technical training, ensuring consistency.
• Helps to identify training needs; assists in establishing a feedback loop to ensure continuous improvement.
• Assists with drafting SOPs, Batch Records, Deviations, CAPAs, etc. Performs revisions as needed to accurately reflect current procedures.
• Appropriately escalates issues / concerns to Area Management for further investigation.
• Works on assignments that are moderately complex in nature, where judgment is required to resolve or escalate operational issues without negatively impacting manufacturing efforts.
• Troubleshoots unexpected results, prioritizes workload, and solves moderately complex problems.
• Possesses ability to work in a team environment or independently, as needed.
• Must adhere to core values, policies, procedures, and business ethics.
• Complies with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Performs miscellaneous duties as assigned.

Required Education, Skills, and Knowledge :

Proficiency in Microsoft Office (Excel, Word, Outlook)

Preferred Education, Skills, and Knowledge :

Experience with cell and gene therapy

Experience with Master Control