GXP Specialist I - Training (RTP, NC Local Candidates Only)

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The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.
Who You Are

The Specialist II, GxP Training role will assist in guiding the execution of GxP Training processes and the associated Learning Management System (LMS) system administration. This role is responsible for day-to-day activities associated with GxP training processes and systems, including the execution of tasks within the LMS, New Hire Orientation, content creation, management, and document archival.

• Assign and process customer service tickets to support all LMS users and administrators
• Assist with testing the LMS for configuration and system upgrades
• Assist with training end-users and administrators on current and new process training within the LMS
• Assist with new hire orientation (NEO) scheduling and facilitation, acclimate new hires to the various training requirements in the LMS, and conduct retraining as needed
• Archive training records according to the site record retention policies
• Create, update, and maintain user information and ensure training records are accurate, complete, and filed in a timely manner
• Perform system administration transactions to support functional units
• Collaborate in the review of GxP training standard operating procedures (SOPs)
• Work cross-functionally with internal and external training administrators to complete company-wide training goals and process improvements
• Assist with employee training files and provide records to those requesting proof of training
• Troubleshoot and resolve standard system issues reported by users and administrator

Minimum Requirements

• Bachelor’s Degree in a related field
• Administrative, customer service or related experience
• Adept at learning to use database computer systems, specifically LMS, EDMS, and QMS
• Able to effectively use MS Office including Word, Excel, and PowerPoint
• Maintenance of LMS certification(s)

Preferred Qualifications

• Experience with Microsoft Visio

Job Location

This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least four days per week in the office. In office requirements could increase based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.