Plastikon Healthcare is looking for a MasterControl System Administrator (SA) responsible for effective provisioning, installation/configuration, operation, and maintenance of MasterControl Quality Management software as a service (SaaS). This individual works closely with the software provider to resolve system issues, propose enhancements, deploy updates, testing and implement additional functionality within the system. The SA will assist project teams and 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 the administration of the entire MasterControl system as it is implemented at Plastikon Healthcare.
Job Description:
Develop and maintain installation and configuration management procedures
Experienced with MasterControl Qx and Mx modules, specifically, Document Control, Training, Maintenance, Calibration, and Change Management
Contribute and maintain system standards
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
Manage Roles, rights, and Access for all MasterControl users
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
Identify and create system reports to support internal and external audit queries
Support governmental, organizational, client, and vendor audits as needed
Other duties as assigned
Qualifications
Education and Experience:
Professional with a minimum of 3-5 years of experience with systems administration in a pharma, biopharma/biotech, or healthcare environment
Previous MasterControl experience required
Experience with 21CFR Part 11 validated systems preferred
Knowledge/Skills/Abilities:
Excellent people, communication, and management skills to create a team environment
Excellent leadership skills to motivate plant personnel and gain their trust and respect.
Excellent verbal and written communication skills
Success working with multifunctional and cross functional teams
Extensive working knowledge of applicable quality and regulatory standards and regulations
Strong project management and time management skills
Demonstrated capability in solution deployment and project management skills
Prior experience working in a fast-paced, emerging growth CMO is preferred
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
LANGUAGE SKILLS
Required reading, writing, and speaking fluently in English.
PHYSICAL DEMANDS
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Visions abilities required by the job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.