Master Control Admin - OQSIE

The Master Control System Administrator (SA) is responsible for effective provisioning, configuration, operation, and maintenance of Master Control Quality Management software as a service (SaaS). This individual works closely with the software provider to resolve system issues, propose enhancements, deploy updates, and test and implement additional functionality within the system.

· The SA will assist process owners with technical issues in the initiation and planning phases of module implementation, including the definition of needs, benefits, and technical strategy, as well as support of staff in executing, testing and rolling out solutions.

· This individual is responsible for administration of the entire Master Control system as it is implemented.

Responsibilities:

· Develop and maintain installation and configuration management procedures.

· Following up on support issues proactively to provide timely updates and resolutions to end users.

· Work with the vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.

· Work with Validation to apply application version upgrades in a timely manner and configure/add new services as needed.

· User administration, 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.

· Support governmental, organizational, client, and vendor audits as needed.

· POC for technical support, improvements, security and integrity controls.

Candidate Requirements:

· Professional with a minimum of 3 years of experience with Master Control systems administration in a pharma, biopharma/biotech, or healthcare environment. Demonstrated capability in solution deployment.

· Understand roles and security required when developing or customizing new solutions.

· The MasterControl System Administrator provides daily administration, support and development of the eQMS, Training and Quality applications.

· Create/Maintain user accounts and Client MasterControl Master User List.

· Coordinate software and hardware modifications using SDLC best practices and Change Controlpolicies.

· Able to perform all major day to day administrative hands-on tasks.

· Provide troubleshooting expertise to end users on an ad hoc basis, consulting with MasterControl as needed.

· Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

· Must have proficient computer skills in Microsoft Word, Excel and Outlook.

· Understanding of 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems.

· Understanding of industry requirements and trends toward preserving data integrity, including FDA Guidance for Industry on "Data Integrity and Compliance with cGMP.”

· Familiarity with and previous experience working with Master Control as a System Administration capacity.

Education and Specific Requirements:

· Bachelor's Degree preferred

· 3 years of experience as an analyst/administrator for an electronic data management system.

· Prior pharmaceutical industry experience preferred.

· Experience with FDA 21 CFR Part 11 validated systems preferred.

· Excellent problem solving and troubleshooting skills.

· Demonstrated ability to interact effectively with customers of all organizational levels

· GxP best practices knowledge

· Current experience as Master Control System Admin

· Quality Assurance background is helpful