MasterControl System Administrator, Quality Assurance - QA13
Menlo Park, California, United States
Location: Menlo Park, CA
Reporting to: Associate Director, Quality Assurance
Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it is in an exciting start-up phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created. This role will report to the Associate Director, Quality Assurance located in Menlo Park, CA and will be responsible for effective installation/configuration, operation and maintenance of the Orchard MasterControl Electronic Document Management System (EDMS),Learning Management Software (LMS), and Quality Management System (QMS). The candidate will work closely with the software provider to resolve system issues, propose enhancements, deploy updates and test and implement additional functionality within the system.
- Develop and maintain installation and configuration management procedures.
- Contribute to and maintain system standards.
- Follow-up on support issues proactively to provide timely updates and resolutions to end
- Work with vendor to troubleshoot and resolve application issues.
- Coordinate and communicate with impacted stakeholders as needed.
- Work with the IT and validations teams to apply application version upgrades in a timely manner.
- Configure/add new services as needed.
- User administrator, including creating, changing and disabling user accounts per approved procedures.
- Work with existing process owners to deploy new modules, providing advanced training to support process owners becoming module power users.
- Work to develop reports, based on needs of end users and management, to enable efficient real-time reporting.
- Bachelor's degree or equivalent education and work experience.
- Professional with a minimum of 5 years of experience with system administration in pharma, biopharma/biotech, or healthcare environment.
- Previous MasterControl experience required, preferably in a system administrator capacity.
- Experience with FDA 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems and data integrity requirements.
- Understanding of databases and data structures.
- Understand roles and security required when developing or customizing new solutions.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
- Excellent problem-solving skills.
- Ability to read, analyze, and interpret general procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Demonstrated ability to interact effectively with company stakeholders at all organizational levels.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused entrepreneurial environment.
- Demonstrated capability in solution deployment and project management is a plus.