Chris Anders Email & Phone Number

Mountain View, Ca, Us

Mountain View, Ca, Us

Providing CSV consultation and validation packages for Egnyte application to clients in Life Sciences.

Rochester, Ny, Us

Responsible for defining, maintaining, overseeing and optimizing IT quality and compliance management systems throughout ACM Global Laboratories. Collaborates with key stakeholders to provide guidance on quality and compliance matters and leads the implementation of key elements of the quality program against strategic priorities. Fosters a quality culture focused on meeting high quality, ethical and regulatory standards. * Generate, review and approve validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.* Provide support for SOPs, qualification protocols, gap assessments, risk assessments, impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.* Assess all Software Development Life Cycle (SDLC) activities and deliverables and provide constructive feedback.* Assist with implementation and adherence to ACM SDLC and PMO policies and procedures.* Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, GxP regulations, FDA 21 CFR Part 11, EU Annex 11, MHRA and GAMP5.* Work with system owners and users across business lines to ensure all stakeholder issues regarding compliance and validation are addressed.* Guide and coordinate Installation Qualification (IQ); Functional Testing (FT), User Acceptance Testing (UAT) and Regression Testing.* Identify, document, troubleshoot and coordinate resolution for system defects.* Support multiple projects and priorities simultaneously while maintaining a quality focus on each.* Support client and regulatory audit and responses. Ensure proactive audits/inspection readiness and internal oversight of associated action plans.

Rochester, New York, Us

* Coordinate all validation activities (including software); ensure constant communication with affected departments and personnel. * Provide leadership in the company’s validation planning and execution processes. Manage and review validation area processes and procedures. * Support validation program, master validation plan, change management and revalidation requirements. * Work with other departments to ensure effective validation planning: define and execute specific validation protocols (software, test method and process validation). * Ensure regulatory compliance in validation processes with FDA QSR and ISO 13485 regulatory requirements. * Oversee validation documentation review and control in the documentation control and change management system. * Use quality tools to determine risk analysis and validation requirements. * Support design control new product teams with validation requirements. * Develop, implement and monitor validation metrics.

New York, New York, Us

QA testing 3 (three) web based applications focusing on overall user experience in a complete Agile environment using SCRUM. In addition to normal software testing functions, I have made the following contributions:- Develop testing scenarios and test scripts that accurately and comprehensively reflect typical days in the lives of the clients we service.- Recommend and implement process improvements for QA testers to track defects, and created a wiki template Software testing matrix for a more consistent QA testing process.- Provide feedback and insight to assist in the on-boarding process of new hires.- Provide a list of items for improvements based on SCRUM certification training and observations from existing SCRUM process.- Work with business partners to define project scope, goals, deliverables and timeline in support of project initiatives.- Partner with business product owner to manage product backlog, including prioritization and estimation.- Support the project team by providing guidance on Agile methodology, and by working with the necessary resources to remediate issues impeding execution; supervise, coach, mentor and motivate project team members throughout the project life cycle.- Identify, manage and work to resolve issues and conflicts within the project team.- Conduct sprint planning and daily stand-up meetings, and coordinate sprint reviews with business stakeholders.- Identify and manage change, issues and risks to the project deliverables and timeline; develop contingency plans as part of risk mitigation- Work with stakeholders and management to define project success criteria, and communicate criteria to involved parties; conduct project wrap up sessions, reviewing scope, accomplishments, issues, lessons learned, and next actions.

- Reviewed new business requirements, specifications, and design documents gaining a thorough understanding of the application and/or infrastructure changes that are to be tested.- Raised issues, questions and concerns before development and testing began.- Provided and validated estimates for assigned tasks and projects lasting 3 months or up to 2 years in duration.- Using the tool HP Quality Center: - Created and executed manual test cases for changes to ensure the change meet the business requirements, specifications and design through the phases of Unit, Integrated, System and Regression testing. - Logged and reported defects with detail to the developer and follow through to ensure that all defects are addressed and resolved. - Communicated testing status to project team members and test manager to ensure timeliness and quality were met.- Maintained test environments (multiple application, data/databases, infrastructure versions) to ensure readiness for testing of future releases, ensure data integrity and currency.- Reviewed user documentation and training materials related to the new applications and/or infrastructure changes for accuracy and completeness.- Contributed to the development of the departmental testing strategy, standards and procedures ensuring consistency and compliance with regulations with regards to Sarbanes-Oxley for a department of 16 QA testers.- Analyzed test output to ensure logic and functionality of application. Assisted in the review of testing turnover packages from Developers and QA testers.- Provided mentoring, technical support and guidance to co-workers and our internal support department.- Led a team of 5 Quality Assurance testers for a combined duration of 3 years.- Worked on a web based application- Tested desktop, windows and web based applications written in .net, Flex, C, C+, Java, HTML, Unix, SQL, Oracle, Informix on Windows and Unix/Linux platforms.

- Ensure quality software is provided for release to production by writing and executing test scripts.- Review requirements, specifications and documentation. Raises issues, questions and concerns prior to development.- Create and modify test scripts to certify system changes. Execute test scripts, validate results, report discrepancies and follow through to ensure all issues are resolved.- Provide and validate estimates for assigned tasks.- Develop test control databases. Maintain test databases and ensure their integrity and up to date.- Identify and create test conditions to support adequate certification testing.- Maintain accurate status of assigned certification activities.- Assist with configuration management tasks on a project (test scripts, source code control, and coordination of requirement changes) as required. Release completed projects into production.- Contribute to the development of testing standards.- Analyze test output to ensure logic and functionality of application. Assist in the review of testing turnover packages from Developers and QA.- Provide technical support and guidance to internal and external departments.- Tested applications using Javascript, HTML, Unix, SQL, Oracle, Informix

- Create system test plans and execute tests of new software releases in a field like environment ensuring a quality product is delivered into production with zero issues.- Create, revise, and edit technical and training documentation.- Set-up, organize, develop and coordinate alpha and beta testing in multiple branch locations around the US.- Lead, assist, and develop project plans and testing teams throughout the alpha/beta test cycle and into production ensuring a quality software release.

- Establish and maintain contacts with state and local tax agencies.- Research and verify payroll tax law changes for state and local jurisdictions.- Ensure payroll system coding follows state and local jurisdictions.- Provide the branches with support and communications on new or changing regulations.- Review publications and services for impact to the company and product.- Write requirements for needed system changes regarding taxation.

- Responsible for knowing and keeping up to date on federal, state and unemployment payroll tax laws.- Serve as liaison between Client, Sales Rep and Branch personnel.- Provide ongoing customer service to clients.- Responsible for balancing, loading and entering client data.- Responsible for problem identification, analysis and resolution.- Research and train various topics for fellow employees.

Associates Degree, Liberal Arts

Bachelors, Science Information Technology