Operations Trainer

Key Responsibilities

• Help design and/or update technical training modules and learning content specifically for manufacturing equipment and processes.
• Deliver classroom, hands-on and on-the-job training covering equipment operation, production KPIs, regulatory requirements, and safety protocols using approved training materials and standard operating procedures and work instructions.
• Incorporate subject matter expertise (SMEs) for appropriate teaching and learning strategies to new/existing employees.
• Evaluate employee performance through formal observations, quizzes, and skills matrices to verify job readiness before personnel begin independent production.
• Ensure all training activities strictly adhere to cGMP (Current Good Manufacturing Practices) and FDA requirements for compliance and audit readiness.
• Maintain meticulous, inspection-ready training files within our LMS (Learning Management System) to support internal and external audits.
• Partner with Quality to identify skill gaps and investigate deviations (such as human error) to implement corrective actions.
• Comply with cGMP, Standard Operating Procedures and Work Instructions.
• Work closely with Plant Management/Supervisors to identify and prioritize training needs.
• Provide training/coaching that ensures corporate and departmental compliance in a timely manner.
• Monitor and evaluate the progress of those trained and provide feedback.
• Assess strengths and weaknesses in employees’ performance and identify areas for further development.
• Ensure that trained employees always perform to a high standard of health and safety regulations.

Job Qualifications

• A High School Diploma/GED is required.
• Bilingual (English and Spanish) is required.
• 3-5+ years of experience in a pharmaceutical or regulated manufacturing industry is required.
• A deep understanding of cGMP, Standard Operating Procedures (SOPs), Food Safety Compliance, & OSHA regulations is required.
• Proficiency in Learning Management Systems, Microsoft Office, and technical writing is required.
• Strong presentation and instructional skills for conducting group and one-on-one training is required.
• The ability to work flexible work schedule as needed to accommodate training needs on all shifts is required.

Position Responsibilities

• Prepare training materials.
• Maintain compliance with regulations.
• Provide ongoing coaching and feedback to ensure health, safety, and performance standards are met.

Physical Requirements

• Must be able to work in production environments, wear appropriate PPE (hearing protection, eye protection, gloves, hairnets, beard net if applicable), and stand for extended periods.
• Must be able to lift, carry, or move objects up to 25 pounds.
• Ability to work in a manufacturing environment which may include exposure to varying temperatures, noise levels, and physical activities typical of a factory setting.
• Must have good hand-eye coordination and fine motor skills for handling materials and operating training equipment.