Production Trainer - GMP/Packaging
Listed on 2026-09-30
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Manufacturing / Production
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job SummaryAs a Production Trainer - GMP/Packaging you are responsible for managing organizational compliance surrounding annual training with a focus on ensuring production employees are trained, competent, and operating in full compliance with cGMP/cGDP standards. The Production Trainer - GMP/Packaging will design and deliver structured training programs with a focus on tactical production skills, support onboarding and skill development, and serve as a key link between Quality, Operations, and Continuous Improvement.
This is a highly hands-on role, combining classroom instruction, administrative oversight, floor-based training, and real-time coaching. The Production Trainer will actively observe operations, identify gaps, and continuously enhance training programs to drive consistent, high-quality execution across production.
On-Site Expectations- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
- Hours may vary based on training needs.
Training Program Development
- Develop structured, cGMP/cGDP-compliant training programs for production roles.
- Build curricula, training modules, and skill-development pathways.
- Create and revise training materials based on process updates, audit findings, and continuous improvement efforts.
Training Delivery & Coaching
- Facilitate onboarding and foundational training for new production employees.
- Deliver hands‑on, floor-based training to reinforce proper execution of procedures.
- Track trainee progress and identify learning gaps.
- Provide targeted coaching and remedial training to achieve performance standards.
Training Documentation & Compliance
- Maintain accurate, complete, and compliant training records for all on‑site training.
- Perform periodic reviews of annual training requirements to ensure documentation meets cGMP/cGDP requirements.
- Ensure traceability and alignment with validated processes.
Production Floor Support
- Provide real‑time coaching to reinforce safety, quality, and procedural adherence.
- Partner with supervisors and line leaders to maintain role certifications and performance standards.
Continuous Improvement Integration
- Collaborate with Operations to integrate process improvements into training.
- Monitor performance metrics, error trends, and training effectiveness.
- Recommend improvements to workflows, training methods, and documentation.
Collaboration & Influence
- Work closely with Production, Quality, and Leadership teams.
- Support corrective action efforts through targeted training initiatives.
- Influence performance and behavior without direct authority.
- Bachelor's degree in a life science, training and development or related field preferred or 10+ years of relevant experience.
- 3+ years of experience creating and delivering training in a cGMP-regulated manufacturing environment preferred.
- 3+ years of hands‑on experience in production, manufacturing, or pharmaceutical operations required.
- 3+ years of experience in a cGMP environment is required.
- Experience in pharmaceutical packaging or regulated manufacturing environments preferred.
- Familiarity with LMS or training tracking systems preferred.
- Experience developing comprehensive training materials, SOPs, or technical work instructions preferred.
- Demonstrated ability to train, coach, and mentor employees effectively.
- Excellent communication skills with the ability to simplify complex processes.
- Strong attention to detail and ability to maintain accurate documentation.
- A…
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