Validation Analyst
Requisition ID 26768
Full/Part Time
Location Natick, MA
Description Delivering on the promise of medical innovation begins at Boston Scientific!
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Validation Analyst
Summary:
Support computer systems validation (CSV) initiatives throughout Information Systems (IS) organization. Work directly with IS project teams to ensure customer satisfaction and compliance with all applicable BSC policies and procedures.
Key Responsibilities (List duties that apply, including Quality)
. Coach / mentor IS project teams regarding application of policies and procedures related to system development life cycle (SDLC), computer systems validation (CSV), software quality and change management
. Assist IS project teams in developing project quality plans to ensure compliance with applicable policies and procedures; identify required activities and deliverables; review and approve project quality plans
. Monitor compliance with applicable policies and procedures by reviewing/auditing project deliverables such as project quality plans, validation plans, requirements specifications, design specifications, test plans, test specifications, test results, test reports, requirements trace matrices, software verification and validation reports, etc.
. Participate in development and/or modification of policies and procedures related to implementation and maintenance of information systems
. Ensure consistency of CSV and software quality practices by working with IS project teams, Software Quality Assurance (SQA) organization, and other corporate compliance groups
. Advise IS project teams regarding industry standards and best practices related to implementation of FDA-regulated information systems
. Train IS project teams on SDLC methodology and associated procedures and templates; develop training materials; conduct training classes
. Assist IS project teams in applying System Change Request (SCR) process; review completed SCR forms and associated deliverables for compliance with applicable policies and procedures
. Conduct post-project reviews; facilitate post-project review meetings; collect and analyze data related to lessons learned and best practices; document findings and recommendations
. Assist IS project teams in preparing for internal and external audits; review and evaluate project deliverables for compliance with applicable policies and procedures
. Assist in investigating and resolving Corrective and Prevention Actions (CAPAs)
. Define IS project metrics; collect and analyze data related to project performance; document findings and recommendations
. Participate in corporate and departmental initiatives aimed at continuous improvement of quality related to implementation of information systems
. Manage small to medium-sized projects; develop project plans, manage execution of projects within approved budget and schedule, etc.
. Build quality into all aspects of work by maintaining compliance with applicable quality requirements
Qualifications:
. Bachelors degree
. 3 - 5 years experience with
FDA Good Practices (GCP, GLP, GMP)
21 CFR Part 11 (Electronic Records / Electronic Signatures)
21 CFR Part 820 (Quality System Regulation)
. Knowledge and experience related to System Development Life Cycle (SDLC)
. Knowledge and experience related to Enterprise Resource Planning (ERP), Manufacturing Execution System (MES), Product Data Management (PDM), Product Life Cycle Management (PLM) and Document Management applications a plus
. Proficiency in MS Office products such as Word, Excel, PowerPoint, Visio, Project and Outlook
. Proficiency in technical writing and presentation
. Ability to work independently and as member of team
. Hands-on experience related to implementation of computer systems
. Strong oral communication skills
. Strong interpersonal skills
. Knowledge and experience related to business processes and applications
. Self-starter with strong, proactive work ethic
. Project management skills
. Ability and willingness to travel to BSC and/or supplier sites (5% to 10%)