SQA SME

Are you a seasoned Software Quality Assurance (SQA) expert with a passion for ensuring the highest standards in software validation? This role offers you the chance to leverage your extensive experience in SQA within a dynamic and forward-thinking environment in San Francisco, CA. This is a 12-month contract position with three openings available, providing the opportunity to make a significant impact on critical IT validation projects.

Responsibilities

• Ensure IT validation packages are inspection-ready and comply with applicable company policies and procedures.
• Work autonomously with related IT contacts and business process SMEs to support SQA in the review, approval, and implementation of regulated IT applications.
• Support continuous improvement and provide input related to the validation strategy for IT changes.
• Collaborate with the development team to build compliance capabilities, ensuring the quality of deliverables meets business needs.

Requirements

• Proven experience in validating systems.
• Proficient understanding of GxP regulations and validation principles.
• Strong analytical skills with the ability to organize work logically and succinctly.
• Highly self-motivated and self-directed.
• Understanding of risk management principles, regulatory requirements, and industry best practices.
• Knowledge of Waterfall and Agile software development methodologies.
• Experience with automated testing and implementation.
• Familiarity with a range of applications/tools, including JIRA, Confluence, HP-ALM, Tosca, Veera, Qtest, and M-Files.
• Effective written and verbal communication skills in English at all levels, providing input and regulatory guidance to project teams.
• Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency.
• Must pass background and reference checks.

Pay

Up to $70/hr, with room for flexibility based on experience.

Schedule

12-month contract position.