• Writes and/or reviews and approves CSV documents. This includes, but may not be limited to, SDLC Documentation, Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, applicable Test Scripts or other documents as may be appropriate.
• Acts as the Quality contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned GxP computer systems
• Write, contribute to or edit, as appropriate, SOPs related to the validation of GxP computer systems and/or the use or administration of the validated system(s).
• Assist in the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable.
• Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs.
• Proactively communicate and collaborate with the business to analyze information needs and functional requirements and deliver artifacts as needed, such as Business Requirements Documents and Use Cases.
• Experience in using enterprise-wide requirements definition and management systems and methodologies are required
• Collaborate with project sponsors to confirm scope and vision
• Act as an expert business resource to software development staff in all phases of the development and implementation process
• Work with project teams and purchased solution vendors to ensure product features and functions have been enabled and optimized
• Understand system interdependencies and collaborate with the project team accordingly
• Track the status of requirements throughout the product lifecycle, redefine as necessary
• Participate in user usability, and acceptance testing
• Communicate key insights and findings to key stakeholders
• Supporting business transition and helping to implement change throughout the organization

Requirements:

• Ability to complete documentation to GDP (Good documentation practices)
• Analytical Instrument and SDLC Metrology Experience
• Experience with a GMP
• Expert SDLC knowledge
• Lab Equipment/ Windows 10 technical use skill set/understanding
• Proven experience in Problem Solving Skills
• Strong critical thinking skills
• Excellent communication skills
• Strong facilitation skills
• Experience in data modeling and supporting tools