Susan Birkeland

In addition to the activities listed for the IT Analyst, the following

• Assist with development and maintenance of validation methodology to guide software development, validation, and maintenance in accordance with applicable Quality/Regulatory requirements, FDA guidance documents on software validation and industry best practices, as directed
• Assist with development and maintenance of validation strategies, policies and SOPs implementing a predicate rule, risk-based approach to fully support the attainment and maintenance of a validated state of compliance for all regulated computerized systems
• Provide interpretation and recommendations on compliance with FDA and EU Regulations regarding Validation related issues, i.e., Electronic Records/Electronic Signatures
• Provide IT Department oversight of the validation of software and qualification of computing infrastructure to ensure validation is correctly and effectively implemented
• Perform periodic review of software applications and formal documentation (including, but not limited to: policies, standard operating procedures, work instructions, etc.), as applicable
• Provide IT Department oversight of the creation, collection, execution, approval and archiving of all validation lifecycle documentation related to the validation of Clinical Trials Division software and hardware systems, including but not limited to: Validation Plan, User Requirement Specification, Functional Requirement Specification, Functional Risk Assessment, Installation Qualification, Operational Qualification, Performance Qualification, Traceability Matrices and Validation Summary Report
• Partner with IT staff to provide validation guidance to ensure compliance with validation methodology, policies and SOPs
• Responsible for development, maintenance and management of IT quality metrics including recommendations and assistance with implementation of improvement initiatives
• Inform management of issues identified during qualification and validation activities
• Recommend appropriate actions to address the issues
• Build customer allegiance by actively seeking information to understand both internal and external customers’ circumstances, problems, expectations and needs
• Perform duties at the direction of IT Management and the Senior Validation Engineers/Analysts in a team environment
• Work in a geographically separated team in different time zones
• Contribute to innovation and process improvement efforts as part of the Practical Process Improvement initiative.

• Assist with development and maintenance of validation methodology to guide software development, validation, and maintenance in accordance with applicable Quality/Regulatory requirements, FDA guidance documents on software validation and industry best practices, as directed
• Assist with development and maintenance of validation strategies, policies and SOPs implementing a predicate rule, risk-based approach to fully support the attainment and maintenance of a validated state of compliance for all regulated computerized systems
• Assist with annual FISMA audit, providing evidence to auditors for impacted systems, address questions, and work to remedy action items as needed.
• Provide interpretation and recommendations on compliance with FDA and EU Regulations regarding Validation related issues, i.e., Electronic Records/Electronic Signatures
• Provide IT Department oversight of the validation of software and qualification of computing infrastructure to ensure validation is correctly and effectively implemented
• Perform periodic review of software applications and formal documentation (including, but not limited to: policies, standard operating procedures, work instructions, etc.), as applicable
• Provide IT Department oversight of the creation, collection, execution, approval and archiving of all validation lifecycle documentation related to the validation of Clinical Trials Division software and hardware systems, including but not limited to: Validation Plan, User Requirement Specification, Functional Requirement Specification, Functional Risk Assessment, Installation Qualification, Operational Qualification, Performance Qualification, Traceability Matrices and Validation Summary Report
• Partner with IT staff to provide validation guidance to ensure compliance with validation methodology, policies and SOPs
• Responsible for development, maintenance and management of IT quality metrics including recommendations and assistance with implementation of improvement initiatives
• Informed management of issues identified during qualification and validation activities
• Recommended appropriate actions to address the issues
• Build customer allegiance by actively seeking information to understand both internal and external customers’ circumstances, problems, expectations and needs
• Perform duties at the direction of IT Management and the Senior Validation Engineers/Analysts in a team environment
• Work in a geographically separated team in different time zones
• Contribute to innovation and process improvement efforts as part of the Practical Process Improvement initiative.
• Assisted in deploying new systems and services into production environment.
• Collaborated with team members to deliver projects within scheduled deadlines.

• Generates content for technical and quality documents, working closely with the IT Project Manager, developers, end users, and Software Compliance
• Performs writing, editing and /or rewriting of complex technical documents and reports and is responsible for detailed analysis and decomposition, outlining, compliance, etc
• Collects and organizes data, charts, and diagrams for Fisher BioServices technical and quality documents
• Writes, edits, and updates complex technical documents, company manuals, capability statements, and other technical or quality documents
• Creates document development templates
• Reviews and edits material for proper use of terminology, style, direction, content, grammar, punctuation and clarity
• Assigns responsibilities to subject experts in regards to information needed for technical or quality documents
• Assists with the preparation of drafts for review by other writers or personnel
• Acts as a liaison between internal departments in order to obtain required proposal information
• Performs ongoing reviews of technical and quality document content for quality of written materials, effectiveness of data exhibits and appendices, compliance with requirements
• Contributes to the quality assurance, trouble-shooting, and contingency planning throughout the process
• Studies data and conducts in-depth interviews with subject matter experts (project managers, technical and operations personnel, and potential subcontractors) to understand procedures, and establish project specifications
• Attends and participates in project meetings, including: strategy, kick-off and lessons learned, in order to obtain valuable information to be included in future projects.