Senior Specialist - Package Implementation

Duration: 1 year. Locals preferred; non-locals may be submitted. Onsite in Sunnyvale, CA.

About the role

The Sr TrackWise Consultant will identify, develop, and implement software solutions, working with process owners to improve process effectiveness and efficiencies. The individual will manage projects and software throughout their lifecycles.

Responsibilities

• Participate in the analysis, configuration, modification, and implementation of IT business systems.
• Identify, communicate, and resolve system issues to maximize IT system benefits using strong communication, analytical, and problem-solving skills.
• Analyze existing business processes and requests, recommending solutions using system standards and best practices.
• Conduct system specifications analysis, create configurations, and develop documentation and process flows.
• Provide detailed specifications and process flows to guide application developers.
• Perform solution designing, requirements definition, functional design, testing, and implementation of IT solutions.
• Support, assist, and train users on new or modified system configurations, highlighting business process impacts.
• Maintain IT business system integrity, application notes, system upgrades, changes, and user updates.
• Collaborate with onsite teams, offshore teams, managers, and executives to ensure high-quality solution releases.
• Comply with regulatory and change control requirements and processes.
• Gather business requirements, perform requirements analysis, and design TrackWise-based applications.
• Create workflows, business rules, TrackWise automation, notifications, and migrate updates.
• Develop TrackWise WebServices (Search/Populate/Transfer) using OWS/IWS.
• Create and implement Crystal Reports.

Requirements

• Minimum 8 years of TrackWise system analysis experience.
• Experience in the medical device manufacturing industry and familiarity with systems regulations (21 CFR Part 11, GxP, GAMP, etc.).
• Strong knowledge of CAPA and complaints processes.
• Experience with TrackWise Quality View is preferred.
• Exposure to integration with SAP systems is preferred.
• Experience working with business end users to gather requirements and build detailed functional design specifications.
• Ability to work on multiple projects concurrently with minimal supervision.
• Familiarity with Software Development Lifecycle (SDLC) processes.
• Strong verbal and written communication skills.
• Contribute to team-building measures such as knowledge management and mentoring.
• Strong knowledge and experience in Java programming.

Benefits

• Comprehensive medical plan covering medical, dental, and vision.
• Short-term and long-term disability coverage.
• 401(k) plan with company match.
• Life insurance.
• Vacation time, sick leave, and paid holidays.
• Paid paternity and maternity leave.

Pay

The range displayed reflects the minimum and maximum salary target for the position across all US locations. Individual pay is determined by work location, job level, skills, experience, and relevant education or training. Additional forms of compensation may include an annual performance-based bonus, sales incentive pay, or other bonus/variable compensation.