Training Specialist (GXP Trainer)

Training Specialist (GXP TRAINER)

12-month initial contract

M-F 8am-5pm

Hybrid opportunity/ M&F WFH

$36-$39/HR based on benefits

Irvine, CA

Orion Group is hiring a Training Specialist for our pharmaceutical client in Irvine CA.

The Training Specialist, (Global GxP Trainer) is responsible for administration of the Learning Management System (LMS) ComplianceWire in support of applicable Research and Development (R&D) functional areas.
Delivers training at a level which requires facilitation of group process in diverse settings; design learning interventions to meet defined needs; works with management to define organizational objectives and design courses to meet those business needs. BS in a learning or closely related discipline, or sufficient practical and transferable experience to demonstrate practical equivalence; understands human learning concepts and has experience designing learning interventions to meet specific business needs.

Training Specialist Responsibilities:

• Collaborate and consult with internal stakeholders in processing training requests to create, revise and maintain curricula, training items and user groups in the Learning Management System (LMS)
• Manage and monitor user accounts/profiles in the LMS
• Process training requests using the GxP Training, Advising and Consulting Intake Request System (GTAC)
• Generate compliance training reports and metrics for GxP Training leaders and R&D stakeholders
• Partner with functional leadership to reconcile training events completed after the assigned due date
• Provide training qualification documentation for audits/inspections
• Contribute to the actions to address audit/inspection findings related to training responsibilities
• Maintain LMS processes and training materials based on current processes/versions of the LMS
• Provide input into continuous improvement for the use of our training tools (LMS, SmartForms, Intake, curricula management tool)
• Troubleshoot/support R&D personnel with questions/issues regarding the LMS
• Participate in training/learning related projects as required
• Participate in global and local meetings

Training Specialist Qualifications:

• Bachelor's degree or equivalent experience; typically in life sciences or engineering
• Minimum of 4+ years quality related experience, preferably in the healthcare industry
• Basic knowledge of GxP requirements; experience in GxP-regulated work environment
• Experience in Quality training desired
• Good verbal and written communication skills
• Excellent organizational skills
• Reliable and independent approach
• Analytical thinking and good comprehension skills
• Excellent communication in a teamwork environment
• MS software (Word, Excel) skillset

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.