Jr. SQA based in Chicago, Illinois.

This contract is for 9 months working on a remote schedule with the site.
Responsibilities

• Ensures IT validation packages are inspection ready and in compliance with applicable Company policies and procedures.
• Works autonomously with related IT contacts and the business process SMEs for this purpose.
• Supports as SQA the testing and implementation of regulated IT applications.
• Ensures continuous improvement and gives input related to the validation strategy for IT changes.
• Collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.
• Ensure document change requests are accurately completed within Documentum.
• Assist in the development of new SOP’s and revision to existing SOP’s where required to maintain compliance with regulatory requirements.
• Provide periodic reports to internal teams for the status of Change Controls, Deviation/non-conformances, and CAPAs within TrackWise.
• Manage and provide updates on Documentum status with respect to legacy imported document as necessary

Requirements

• Familiarity in understanding of GXP regulations and validation principles
• Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
• Minimum 1-3 years of experience in CSV or Life Science Industry
• Familiarity with risk management principles, regulatory requirements and, industry best practices.
• Familiarity with Waterfall and Agile software development practices
• Familiarity with automated testing and implementation
• Familiarity of CAPA, Deviations/Non-conformances
• Experience working with electronic document management systems such as Documentum.
• Familiarity with JIRA, Confluence, HP-ALM or other continuous integration tools
• Flexibility to adapt to changing priorities
• Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams
• The 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.
• Preferred experience with the following tools: AQC (HP ALM), M-Files document management, JIRA, Confluence, MS Teams, Data Lake implementation in AWS, Tresata (Apache Hadoop), Databricks, Github

Location: Remote

Job Types: Full-time, Temporary

Pay: $32.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• SQL: 1 year (Preferred)
• Selenium: 1 year (Preferred)
• Test automation: 1 year (Preferred)

Work Location: Remote

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