SQA SME

Software Quality Assurance Specialist

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a SQA SME. Position Type:
Contract Onsite

Required:

• Strong validation resource with 10+ years experience
• Previous experience validating systems
• Proficient in understanding of GxP regulations and validation principles
• Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner
• Highly self-motivated, self-directed
• Understanding of risk management principles, regulatory requirements and industry best practices
• Knows the difference between Waterfall and Agile software development methodologies
• Previous experience with automated testing and implementation
• Experience with multiple tools/applications such as but not limited to JIRA, Confluence, HP-ALM, Tosca, Veera, Qtest, M-Files, Microsoft Teams and other tools such as the following are a plus:
  Data Lake, AWS, Databricks, Github, or other continuous integration tools
• Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams
• Role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state
• Software quality assurance with review and approval experience for SDLC deliverables
• Experience should have earlier in career in SDLC/Software validation with writing and execution of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release)
• Also, should have good experience in review of CAPA's, Change Control and Defects as it applies to Software Validation while concurrently having good soft skills such as a good and effective communicator and vocal during meeting and projects

Responsibilities:

• Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures
• Work autonomously with related IT contacts and the business process SMEs for this purpose
• Support as SQA in the review and approval and implementation of regulated IT applications
• Ensure continuous improvement and gives input related to the validation strategy for IT changes
• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met

Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Trusha at  to learn more