Regulatory Training Specialist (Plasma Center)

Kedrion Biopharma GmbH; Buffalo, Northern (NY, KY); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Work-Life Balance

Career Growth

Extra Perks

Job summary

Kedrion Biopharma Inc. is seeking a Training Coordinator to manage and execute the training program within a plasma collection center. You will work with center leadership to ensure staff are trained, certified, and compliant with FDA cGMP 21CFR and EU GMP standards.

Responsibilities include new hire orientation, maintaining training records, updating the LMS, and driving continuous improvement in training materials, SOP updates, and safety practices in a regulated environment.

Qualifications

• High school diploma or equivalent.
• Minimum of one year of training experience in a customer service setting.
• Must be certified in all operational areas or complete training and competency assessments within 90 days of hire.
• Strong organizational and communication skills.
• Ability to work in regulated environments and adapt to changing temperatures, including cold storage areas.

Responsibilities

• Training Program Management: coordinate and administer the center’s training program, ensuring regulatory alignment.
• Collaboration & Planning: partner with Regional Field Training Manager and center leadership to implement training initiatives and schedule training periods.
• Training Delivery & Documentation: conduct new employee orientation and training sessions; maintain training records and certifications.
• Learning Systems & Materials: manage courses in the LMS and keep the training manual current.
• Compliance & Observation: monitor SOP compliance and escalate training delays.
• Continuous Improvement: stay current with new materials and SOP changes; deliver training on new processes.
• Operational Support: maintain a clean, organized work environment and ensure data integrity and confidentiality.
• Safety & Standards: follow SOPs and OSHA guidelines; promote safety culture.

Skills

Organizational skills

Communication skills

Training experience

Regulatory compliance

Education

High school diploma

Tools

Learning Management System (LMS)

Job description

Kedrion Biopharma Inc. is seeking a Training Coordinator to manage and execute the training program within a plasma collection center. You will work with center leadership to ensure staff are trained, certified, and compliant with FDA cGMP 21CFR and EU GMP standards.

Responsibilities include new hire orientation, maintaining training records, updating the LMS, and driving continuous improvement in training materials, SOP updates, and safety practices in a regulated environment.