United Therapeutics QA Specialist III, Training in Silver Spring, Maryland

The Job Details are as follows:

What we do

United Therapeutics is a biotechnology company that focuses on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them. Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.

How you’ll contribute

The QA Specialist III - Training is responsible for day-to-day activities associated with GMP training processes and systems including execution of tasks within the Learning Management System (LMS). This role supports and/or executes (depending on the task) GMP training activities, ensuring continued compliance with GMP training practices and documentation requirements.

  • Execute system administration activities for the GxP LMS including curricula entries/updates, individual training events, training-related information entry, data pulls, etc.

  • Responsible for scheduling, developing and facilitating in on-boarding new hires in new hire training programs and other Quality related training

  • Collaborate and support new approaches, practices, and processes to improve the efficiency of training services offered

  • Train users on the LMS

  • Support managers in the development of site department and role-specific curricula and maintain curricula in LMS

  • Assist in the development or revision of SOPs specific to GxP Training, LMS, and Quality Systems.

  • Review training records for accuracy and completeness, input internal and external training activities including training related information into the MasterControl, QMS, and maintain records according to site record retention policies

  • Provide training support for individuals and teams enterprise-wide

  • Support validation activities as requested

  • Perform other duties as assigned

For this role you will need

Minimum Qualifications

  • Bachelor’s degree required

  • 3+ years of relevant pharmaceutical or biologics industry experience

  • 7+ years of training experience

  • Basic knowledge of US FDA, EU, and JP GxP requirements

  • Working knowledge of Word processing, Excel spreadsheets, Presentation applications, e-mail software, and general training software programs

  • Must be able to travel up to 10%

Preferred Qualifications

  • Experience in a quality role or exposure to biologic, solid oral dose, or sterile manufacturing processes

  • MasterControl or other electronic Learning Management System experience

  • Electronic Document Management System, TrackWise, Adept, ISOTrain, or ComplianceWire experience

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.