Description
Primarily responsible for authoring, reviewing/auditing, and approving project documentation associated with the SDLC to support corporate, division, FDA, and other regulatory requirements for Quality Assurance. This role is accountable for determining changes or improvements needed to support the QA System and business driven objectives.In addition to these primary areas of focus, quality assurance will perform project work related to:
- Infrastructure (Hardware or Layered Software Installations)
- Application quality
- Compliance initiatives
- Validations
- Responsible for compliance with applicable corporate and division policies and procedures.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Accountable for ensuring that project documentation for the software development life cycle (SDLC) is followed for quality and
non-quality applications. - Provides project management for validation or SDLC activities including: Client QA time estimates; Provides software validation/QA guidance to clients and QA team; Organizing validation or SDLC material for library or electronic storage; and Coordinate and/or lead validation review board meetings.
- Responsible for assessing risk and applying risk based approach strategies without compromising compliance.
- Recommend system release readiness and generate key project deliverables that are approved by senior managers and reviewed by regulators.
- Responsible for evaluating system (applications, layered software, & hardware) implementations or changes for impact on other systems.
- Perform divisional audits against Polices, Procedures, Processes, Guidelines, etc. under the guidance of senior QA staff.
- Responsible for coordinating, facilitating, and reporting inspections or observations.
- Recommend modification to quality and non-quality systems and drive changes through the approval process.
- Develop and maintain written policies and procedures related to the SDLC.
- Perform Quality Engineering function related to process improvements, metrics collection and analysis, and adherence to defined practices.
Familiarity with regulatory requirements, prior QA experience, Familiarity with the software development life cycle (SDLC)