What are the responsibilities and job description for the GxP Training Specialist position at INCOG BioPharma Services?
INCOG is seeking a highly engaging and detail oriented GxP Training Specialist for comprehensive training program management and delivery.
The Specialist will be responsible for assisting in the ongoing management of the site’s training curricula, training assessments, new hire and ongoing training, as well as working closely with the technical and operational departments on the deployment of their On-The-Job training courses. The person filling the role will be a secondary Training Administrator within INCOG’s electronic Quality Management System (Veeva Vault) following the guidance of the GxP Training Manager. The ideal candidate is someone looking to leverage their organizational and facilitation skills in the management and delivery of training to support GMP aseptic manufacturing.
Essential Job Functions:
- Application and advocacy of INCOG GxP Training Policies and SOPs
- Support of a broad variety of classroom training facilitation, including new-hire onboarding
- Implementation of various multimedia learning methodologies
- Administration for the GxP Training program within the Veeva Vault electronic Quality Management System
- Support of sitewide curriculum system management, including annual curriculum reviews
- Management and support of assessments/effectiveness of training across training types
- Routine reporting on Training System, statuses, and compliance health and metrics
- Supporting the provision of training records to client and health authority audits
Special Job Requirements:
- Certification (or equivalent experience) in Education, Training, Technical Writing, Communications, or similar fields
- A minimum of 3 years of experience in training content facilitation experience
- A minimum of 2 years of experience in training program administration, preferably in the Pharmaceutical industry or other regulated industry
- A minimum of 1 year experience in training program management via an electronic Quality or Learning Management System (eQMS, eLMS)
- Strong written and verbal communication skills
- Excellent customer service/ collaborating skills
Additional Preferences:
- Degree and/or certification(s) focusing on adult learning principles
- Experience in training delivery and administration, preferably in an aseptic manufacturing facility.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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