Job Description

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

WHO?:

INCOG Biopharma Services in Indianapolis, IN is hiring a GxP Training Facilitation Specialist to cover either 2nd shift (2pm to 10:30pm) or 3rd shift (10pm-6:30am) who will report to 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, specifically within inspection activities.

WHAT?:

• Conduct and deliver classroom-based training, on-the-job training (OJT), and assessments/tests for new hires and ongoing employee development relating to inspection activities, and also in GxP principles, quality systems, regulatory requirements, technical processes, and role-specific competencies where necessary.
• Maintain complete and accurate training records and testing documentation within the eQMS in full compliance with FDA, ICH GxP, and INCOG requirements.
• Review training progress and collaborate with departments to develop action plans for improving training compliance and competency achievement.

YOU:

The ideal candidate will have a Bachelor’s degree in Science, 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.
• Demonstrated practical knowledge of GxP manufacturing and regulatory requirements for pharmaceuticals, (FDA 21 CFR Parts 11 and 211 and ICH GxP).
• Degree and/or professional certification(s) focusing on adult learning principles or training and development (e.g., Certified Professional in Training and Development [CPTD], Certified Training and Development Professional [CTDP], or equivalent).

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

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