Regulatory Training Specialist

KEDPLASMA LLC

Chicago (IL)

On-site

USD 52,000 - 80,000

Full time

5 days ago
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Benefits offered by this job

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Job summary

KEDPLASMA LLC is seeking a Training Coordinator to manage the center's training program, ensure regulatory compliance, and drive staff development within a plasma collection center in the United States. You will collaborate with center leadership and regional teams to certify staff and maintain training records, while upholding safety and quality standards.

The role emphasizes coordination, documentation, and continuous improvement in a regulated environment, with responsibilities spanning

Qualifications

  • High school diploma or equivalent required.
  • Minimum of one year of training experience in a customer service setting (e.g., medical office, retail, blood or plasma collection center).
  • 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 alignment with regulatory guidelines including FDA cGMP 21CFR and EU Good Manufacturing Practices.
  • Collaboration & Planning: Partner with the Regional Field Training Manager and center leadership to implement training initiatives, assign Designated Trainers, and schedule training periods that support operational needs.
  • Training Delivery & Documentation: Conduct new employee orientation and facilitate training sessions based on audit findings or operational needs. Maintain accurate training records for all staff and positions and ensure timely completion of re-certifications and updates.
  • Learning Systems & Materials: Manage training courses in the company’s LMS. Keep the Donor Center Training Manual current and ensure training materials are available and up to date.
  • Compliance & Observation: Monitor SOP compliance through routine employee observations and follow-ups. Escalate delays in training progress and notify management of specific training requirements.
  • Continuous Improvement: Stay current with new training materials, SOP changes, and technology updates. Deliver training on new processes and tools and identify opportunities to enhance the training program.
  • Operational Support: Maintain a clean and organized work environment, ensure adequate supplies are available, and uphold data integrity and confidentiality of personnel and donor information.
  • Safety & Standards: Follow all SOPs, OSHA guidelines, and company policies. Promote a culture of safety, respect, and professionalism in all interactions.

Skills

Organizational skills
Communication skills
Regulatory compliance
Temp-controlled work environment

Education

High school diploma or equivalent

Job description

KEDPLASMA LLC is seeking a Training Coordinator to manage the center's training program, ensure regulatory compliance, and drive staff development within a plasma collection center in the United States. You will collaborate with center leadership and regional teams to certify staff and maintain training records, while upholding safety and quality standards.

The role emphasizes coordination, documentation, and continuous improvement in a regulated environment, with responsibilities spanning

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