Nicole Landeck

Provide cross-functional project leadership to all members of software development project teams Develop a plan for integrating each product into the overall NSABP software structure and provide project status reports to the Head of Applications Programming Assemble e a team that includes representatives of each user group impacted by the software integration of both commercial software products and products that are developed Ensure that the process being implemented is discussed and the documented soft

Lead and implemented SQA for the first time locally in Hamburg for all of the above types of customized engineering systems and ensured they were in accordance to local, global, EMEA and FDA-GCP regulations Authored test plans, test cases; performed assembly line functional testing, supervised UATs and authored test reports. Streamlined testing process across engineering in Hamburg Coordinated globally with San Francisco headquarters to ensure SQA policies and procedures in place were being followed in Ha

Ensured that project responsibilities were defined, risk assessments completed and that the CMMI method was used from project planning through the end of the project and actions tracked to closure Ensured that project responsibilities were defined, risk assessments completed and that standard methods were used from project planning through the end of the project and actions tracked to closure Responsible for monitoring the compliance of projects to internal processes during the product development lifecyc

Quality Coordinator on Global teams and IT Validation Analyst in Germany Created validation package: vendor analysis and evaluation report, vendor management plan, validation plan, requirements, design and system configuration, source code review, test plan, test cases and scripts, test summary report, security plan, business continuity plan, disaster recovery plan, validation report, and yearly periodic reviews of the validated system according to local and global CSQ procedures, policies, EMEA and FDA-GM

Integrated QA within IT according to ISO 9000 Standardized Requirements, Test Plans, Process improvements

Authored requirements documents, test plans, test cases and test reports according to local CSQ procedures, policies and FDA-GCP regulations Analyzed, designed, developed the data entry/edit systems and then performed the functional system testing Reviewed case report forms (CRF's), created modules according to CRF's and then tested Project managed contractors to build and manage changes of systems and peer reviewed contractors and coworkers documentation and systems built for quality assurance Prepared

Computer Science