Position Summary:

The Systems Analyst is responsible for meeting the software application service level agreements and evolving the existing software system applications and architecture in collaboration with the business end-user community. In addition, Systems Analyst serves the end-user business community and the governing corporate quality team, to ensure software solutions are well understood and built for purpose.

Key Responsibilities:

• Assists with managing Quality Management systems: troubleshooting system configuration issues, preparing and managing quarterly releases. Escalates application or system related issues to application owner and vendor.
• Defines and implement Quality Management System policies, implementation Standards, training content and methodology
• Maximizes the use of all functions and features of System to benefit the organization
• Possess a clear understanding of Systems Development Lifecycle (SDLC)
• Coordinates and manages functional, user acceptance, validation and performance testing.
• Secures the integrity of the Trackwise Digital Quality Management system by developing system access, monitoring, control, and evaluation; establishing and testing disaster recovery policies and procedures; completing back-ups; maintaining documentation.
• Upgrades Quality Management system by conferring with vendors and services; developing, testing, evaluating, and installing enhancements and new software.
• Establishes Quality Management system specifications by analyzing access, information, and security requirements; designing business unit configurations.
• Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
• Responsible for coordination, configuration and implementation and delivery of business process modules (CAPA, Complaints, Supplier Audit, Document Management, Management of Change etc.) to the business within scheduled release window.
• Possess an understanding of deviations/investigations
• Maintains expertise in validation/compliance and develops a greater understanding of Quality Management Systems.
• Maintains Quality Management system (MasterControl, Trackwise Digital) performance by performing system monitoring and analysis; troubleshooting system configuration issues; operating and system management; and escalating application problems to vendor.
• Leads and coordinates multi-specialty teams from business, vendor and various IT groups implementation projects
• Assists in preparing Functional and Technical specifications through the review process collaborating with the solutions delivery team and Subject Matter Experts.
• Knowledge of IT Service Management (Incident Management, Change Management, Problem Management and Service Requests Management).
• Experience with ServiceNow ITSM enterprise application

Requirements/Qualifications:

• Bachelor’s Degree in Computer Science or equivalent combination of education and experience required
• Demonstrated System Administration and User Management experience required
• Technical writing and Document Management experience is a plus
• Background in Quality Management System or Trackwise Digital is strongly desirable
• Ability to communicate effectively on all levels within the organization
• Experience with system support/system administration
• Knowledge of SOAP and REST based web services technologies is a plus.
• Familiarity with industry best practice and standards such as GxP, CMMI, SPI, GAMP, ITIL, COBIT, Risk Management and 21 CFR Part 820 Quality System Regulation
• Excellent analytical abilities, creative problem-solving skills and strong planning and organizing capabilities
• Ability to understand both the business and the technical aspects of the applications supported
• Experience qualifying and maintaining a validated computer system.
• Bachelor’s Degree in Computer Science
• Demonstrated application administration experience
• Must have experience with Apex Programming language in Salesforce/Force.com. Salesforce certification is strongly desirable.
• Experience with system support/system administration
• Ability to drive multiple initiatives in a fast-paced environment.
• Excellent analytical and problem-solving skills, with strong planning and organizational capabilities
• Experience with Computer System Validation (CSV) is desirable