GxP Systems Administrator

Ardelyx   •  

Fremont, CA

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 33 days ago

Ardelyx® is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. Our primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia, patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. We have also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C. 

The GxP Systems Administrator role is responsible for day-to-day administration, end user support, system configuration, and resolving general system issues to support daily business activities.  This role is also responsible for implementing new GxP systems, maintaining GxP systems in the validated state, initiating change controls for changes required prior to implementation.  This role will report to the Sr. Director of Quality Assurance.

 

Position Responsibilities: 

  • Provide day-to-day administrative support for multiple SaaS based applications (e.g. Veeva, ComplianceWire, and ClinPlus)
  • Triage and resolve issues reported by users in the various applications
  • Provision new users, manage workflows, manage system configuration, and general end user assistance, for example:
    • Configuration of users and groups, document types, properties, lifecycles and workflows, picklists, notifications, and security
    • Bulk import/export of content and data
    • Ad hoc training of users and administrators
    • Analysis and deployment of new product features
    • Creation of regular and ad hoc customer reports
  • Work with business owner and quality unit for the selection, validation, and implementation of GxP systems. Adhere to industry best practices for change and release management
  • Configure the GxP system to align with business processes and to meet the user requirements
  • Support user acceptance testing and data migration testing
  • Initiate change controls for the validated GxP systems. Document all changes to applications per internal controls
  • Assess new features/release and provide impact assessment
  • Manage various environments and migration of configurations from one environment to another.
  • Participate in the development of knowledgement management and training content
  • Create technical documentation and conduct end user training
  • Engage managed services only as needed for significant projects, determine demand for managed services
  • Perform other related duties as assigned from time to time based on company needs

 Position Requirements: 

  • Bachelor’s degree or equivalent relevant experience
  • Certified Veeva System Administrator
  • 3+ years of experience as a systems administrator for Veeva vaults, such as QualityDoc, RIM, and eTMF, in life sciences industry is a must
  • Hands on experience with administration of SaaS applications such as ComplianceWire and ClinPlus is desirable
  • Experience with Single Sign on Technologies such as Okta is desirable
  • Advanced technical and analytical skills
  • Ability to work independently with minimal guidance in a fast-paced environment
  • Ability to quickly understand user requirements and needs and articulate potential solutions
  • Excellent time management skills
  • Good verbal and written communication skills