GxP Training Facilitation Specialist; 2nd or 3rd Shift

GxP Facilitation Training Specialist (2nd or 3rd Shift)

Are you an inspection expert looking for your next career move?

INCOG are looking for a GxP Training Facilitation Specialist to join their team!

This exciting chance to join the team is offered by INCOG Biopharmaceutical Services, who are continuing to build their state of the art sterile injectable CDMO. Having won the Best Places to Work in Indiana 4 years in a row, INCOG is the perfect place to take those next career steps!

INCOG Biopharma Services in Indianapolis, IN is hiring a GxP Facilitation Training Specialist on either 2nd or 3rd shift (candidate preference) who will be working closely with the GxP Training Manager. They will be instrumental in ensuring that all personnel possess the knowledge, skills, and competencies needed to perform their duties safely and in full compliance with FDA and ICH GxP expectations.

This role offers the opportunity to work at INCOG’s state‑of‑the‑art sterile injectable CDMO during an exciting time of growth, contributing towards a better path to market for life‑saving drugs.

The role responsibilities are, but are not limited to:

• Conduct and deliver classroom‑based training and on‑the‑job training (OJT) for new hires and ongoing employee development. Deliver engaging and clear instruction relating to inspection activities, and also deliver training in GxP principles, quality systems, regulatory requirements, technical processes, and role‑specific competencies where necessary. Adapt delivery methods and communication styles to diverse learning styles and technical backgrounds across multiple departments.
• Develop and administer uniform learning assessments and tests. Assess and evaluate trainee progress, comprehension, and competency achievement. Analyze assessment results and identify individuals requiring remedial training or additional support. Track and report learning outcomes and training effectiveness metrics.
• Maintain complete and accurate training records and testing documentation within the eQMS in full compliance with FDA, ICH GxP, and INCOG requirements. Ensure traceability, completeness, legibility, and accessibility of all training records. Support preparation of training documentation for client and health authority audits.
• Mentor and coach employees to support their development and competency achievement. Demonstrate strong coaching skills including the ability to assess, evaluate, develop, motivate, and empower learners. Provide constructive feedback and guidance to support continuous learning and professional growth.
• Execute approved training curricula and programs as designed. Identify opportunities for training delivery improvements and effectiveness enhancements. Partner with training leadership and subject matter experts to refine training methods and content clarity.
• Ensure adherence to all regulatory, quality, and Environmental Health & Safety (EHS) requirements in all training activities. Maintain current knowledge of GxP principles, FDA guidance, and inspection findings related to training compliance. Serve as a resource for training‑related inquiries and best practices.
• Develop and maintain collaborative relationships with trainees, peers, colleagues, and internal clients across the organization. Work closely with multiple departments to understand their training needs and ensure effective knowledge transfer. Communicate training progress and compliance status to relevant stakeholders.
• Review training progress and collaborate with departments to develop action plans for improving training compliance and competency achievement. Participate in training continuous improvement initiatives and process enhancements. Support onboarding programs to ensure consistent, timely training delivery for new hires.

The ideal candidate will have a Bachelor’s degree in life sciences, pharmaceutical sciences, education, QA, or related field as well as a minimum of 2‑3 years of hands‑on training delivery within inspection activities. Other requirements include:

• Must pass health and visual check and eye inspections annually for visual acuity and color blindness. Failure in vision test or annual…