Sr TrackWise Consultant

eTeam; Sunnyvale (CA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

eTeam in Sunnyvale, CA seeks a Sr TrackWise Consultant to identify, develop and implement software solutions within regulated environments, working with process owners to improve effectiveness and manage projects through their lifecycles. You will bring deep TrackWise expertise including TrackWise Configuration, WebServices and Crystal Reports, plus strong Java development skills.

Collaborating with onsite and offshore teams, you’ll ensure compliance with 21 CFR Part 11 and related standards

Qualifications

• Minimum 8 years of TrackWise System Analysis experience.
• Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications.
• Create workflows, Business rules, TWC automation, Notifications and Migrate updates
• Create TrackWise WebServices (Search/Populate/Transfer) using OWS/IWS.
• Create and Implement Crystal Reports
• Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.)
• Knowledge and good understanding of CAPA and Complaints processes
• Exposure to integration with SAP systems preferred
• Experience on TrackWise Quality View is preferred
• Experience working with business end users, gathering requirements and building detailed functional design specifications
• Ability to work on multiple projects concurrently
• Ability to work with minimum supervision or guidance
• Familiarity with Software Development Lifecycle (SDLC) processes
• Good verbal and written communication skills
• Should contribute in team building measures like Knowledge Management & Mentoring

Responsibilities

• Directly participate in the analysis, configuration, modifying and implementation of IT Business Systems
• Demonstrate good communication, analytical and problem-solving skills to help identify, communicate and resolve system issues in order to maximize the benefit of IT systems
• Analyze the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices
• Conduct analysis of system specifications, configurations and develop appropriate documentation
• Create detailed specifications and process flows to provide direction to application developers
• Perform solution designing, requirements definition, functional design, testing and implementation of IT solutions
• Support, assist and train the users on new modified system configurations highlighting the impact on business processes
• Maintain IT Business system integrity and application notes, system upgrades, changes, and user updates
• Work closely with onsite team, off shore team, managers and executives to ensure the release of high quality solutions
• Comply with regulatory and change control requirements and processes

Skills

TrackWise Configuration

TrackWise Web Service Development

TrackWise Crystal Reports Development

Java programming

Job description

Job Title: Sr TrackWise Consultant

Duration: 12 months

Location: Sunnyvale, CA (Hybrid)

Top Skills

• TrackWise Configuration
• TrackWise Web Service Development
• TrackWise Crystal Reports Development
• Strong knowledge and experience in Java programming,

Detailed Job description

Position Overview: Person will be responsible for identifying, developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. Individual will also be accountable for managing projects and software throughout their respective lifecycles.

Roles and Responsibilities

• Directly participate in the analysis, configuration, modifying and implementation of IT Business Systems
• Demonstrate good communication, analytical and problem-solving skills to help identify, communicate and resolve system issues in order to maximize the benefit of IT systems
• Analyze the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices
• Conduct analysis of system specifications, configurations and develop appropriate documentation
• Create detailed specifications and process flows to provide direction to application developers
• Perform solution designing, requirements definition, functional design, testing and implementation of IT solutions
• Support, assist and train the users on new modified system configurations highlighting the impact on business processes
• Maintain IT Business system integrity and application notes, system upgrades, changes, and user updates
• Work closely with onsite team, off shore team, managers and executives to ensure the release of high quality solutions
• Comply with regulatory and change control requirements and processes

Skill/Job Requirements

• Minimum 8 years of TrackWise System Analysis experience
• Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications
• Create workflows, Business rules, TWC automation, Notifications and Migrate updates
• Create TrackWise WebServices (Search/Populate/Transfer) using OWS/IWS.
• Create and Implement Crystal Reports
• Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.)
• Knowledge and good understanding of CAPA and Complaints processes
• Exposure to integration with SAP systems preferred
• Experience on TrackWise Quality View is preferred
• Experience working with business end users, gathering requirements and building detailed functional design specifications
• Ability to work on multiple projects concurrently
• Ability to work with minimum supervision or guidance
• Familiarity with Software Development Lifecycle (SDLC) processes
• Good verbal and written communication skills
• Should contribute in team building measures like Knowledge Management & Mentoring