Quality Systems Administrator (MasterControl)
At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for a Quality Systems Administrator.
This position provides day-to-day administration, support and development of the QMS, Training and other Quality related applications.
Creates and maintains user accounts.
Creates and maintains system user groups, roles, workflows and curriculums.
Coordinates software and potential hardware modifications to the system(s) using Software Development Life Cycle (SDLC) best practices in conjunction with established Change Control policies.
Participates in testing and executing validation test scripts.
Creates and maintains all operational procedures relevant to the applications and trains the departments as necessary with respect to any changes.
Maintains application knowledge, including staying current on software capabilities and availability of new functionality and updates from the software vendor.
Acts as the Point of contact for technical support; ensures accuracy and completeness of data and implements improvements; establishes and maintains security and integrity controls.
Maintains familiarity with GxP best practices and company specific change control SOPs
Interfaces with internal customers for the successful deployment and maintenance of the EDMS and Training applications.
Engages and works with application software vendors and/or consultants to further configure the system, deploy functional enhancements, and correct configuration issues
Provides incident diagnosis and support business users in the management and timely resolution of technical incidents.
Other duties as assigned.
BS/BA in Computer Science, Information Technology or equivalent discipline.
4 years’ experience in the pharmaceutical or biotechnology industry.
Knowledge of GxP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance
Minimum of 4+ years' experience in MasterControl or Compliance Wire administration or a similar system administration work.
Must possess strong knowledge of systems development life cycle, application development or systems integration.
Knowledge of SQL, JQuery and Crystal Reports desirable.
Equal Opportunity Employer/Veterans/Disabled