MasterControl System Administrator

Regulatory San Diego, California


Description

The MasterControl System Administrator is responsible for effective provisioning, installation/configuration, operation and maintenance of MasterControl Quality Management software as a service.  The incumbent will work closely with the software provider to resolve system issues, propose enhancements, deploy updates and test and implement additional functionality within the system.

 

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • 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 users.
  • Work with vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.
  • Work with IS 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.

 

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Education and Experience Requirements

  • Bachelor's degree or equivalent education and work experience.
  • 3 years of experience as an analyst/administrator for an electronic data management system.
  • Prior pharma industry experience preferred.
  • Experience with FDA 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems.
  • Excellent problem-solving and troubling skills.

 

Skills and Qualifications Requirements

  • 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.
  • 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.
  • Demonstrated capability in solution deployment and project management is a plus.
  • 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.

 

LANGUAGE 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 customers at all organizational levels.

 

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to perform all major day to day administrative hands-on tasks.

  

WORK ENVIRONMENT 

The noise level in the work environment is usually quiet.

 

Qualified applicants are considered for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital status, any disability, or any other characteristic protected by applicable State or Federal civil rights laws.