GxP Training Facilitator (Second/Third Shift)

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 95,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN seeks a GxP Training Facilitation Specialist to design and deliver comprehensive training across the organization. You will conduct classroom and on-the-job training, assess competency, and maintain audit-ready training records to meet FDA/ICH GxP standards.

The role includes mentoring, curriculum execution, and collaboration with multiple departments to ensure effective knowledge transfer and continuous improvement.

Qualifications

• Minimum 2–3 years of hands-on training delivery or OJT experience.
• Knowledge of GxP manufacturing and regulatory requirements (FDA/ICH).
• Experience in regulated pharmaceutical environments or manufacturing.
• Excellent verbal and written communication with diverse audiences.
• Ability to develop assessments and provide constructive feedback.
• Strong organizational skills and attention to detail.

Responsibilities

• Deliver classroom and on-the-job training across departments.
• Develop and administer uniform learning assessments and track outcomes.
• Maintain training records within the eQMS with audit-ready documentation.
• Mentor and coach employees to improve competency and performance.
• Execute approved training curricula and optimize delivery methods.
• Ensure compliance with regulatory and quality requirements.
• Collaborate with stakeholders to address training needs and progress.
• Support onboarding and continuous training improvement initiatives.
• Pursue ongoing professional development in instructional practices.
• Schedule training to accommodate INCOG operations.
• Perform other duties to support quality and operations.

Skills

Training Delivery

Competency Assessment

Training Records

Mentoring

Curriculum Execution

Regulatory Compliance

Cross-Functional Collaboration

Training Program Support

Self-Directed Learning

Flexible Scheduling

Education

Bachelor’s degree in life sciences or related field

Adult learning certification (CPTD/CTDP)

Tools

Veeva Vault

eQMS software

Job description

INCOG BioPharma Services in Fishers, IN seeks a GxP Training Facilitation Specialist to design and deliver comprehensive training across the organization. You will conduct classroom and on-the-job training, assess competency, and maintain audit-ready training records to meet FDA/ICH GxP standards.

The role includes mentoring, curriculum execution, and collaboration with multiple departments to ensure effective knowledge transfer and continuous improvement.