- Personnel Management:
- Provide training, in area of expertise or Subject Matter Expert (SME) role, to team members as required
- Resource Management:
- Manage and prioritize your workload; escalate conflicting schedules to Test Analyst Level IV or GL
- Assist in assessing timeline deliverables and budget estimates
- Participate in project status and requirements meetings
- Ensure the timely delivery of all clients (internal and external) deliverables
- Perform other work-related responsibilities as assigned by management
- Process Management:
- Ensure your full understanding of, and compliance to, the Almac SDLC
- Review and challenge requirements focusing on patient safety and study risk factors
- Write clear, concise and thorough Test documents based off the latest client approved requirements
- Lead test case review and execute test cases according to the defined test methodology
- Define logical, risk-based test approach for each project assigned to you
- Escalate issues to Test Analyst Level IV or GL as needed
- Track and control the change management process within your projects
- Participate in client and FDA system audits as required
- Assist quality assurance with responses to audit findings
- Take full ownership through to completion of all tasks assigned; ensure proper hand off and communication to next owner
- Provide support and act as point of contact person for studies where Testing Analyst was the original testing resource
- Other responsibilities as assigned by management
- HS/GED with 3+ years working experience associated to the role requirements that demonstrate the ability to perform tasks, OR
- Bachelor’s Degree in related field, OR
- Bachelor’s Degree in any field with 3+ years of working experience associated to the role requirements that demonstrate the ability to perform tasks.
- 2 years of experience working in a regulated formalized software testing environment
- Moderate experience creating and implementing manual test suites in a formal SDLC environment
- 2 years of experience using change management tools
- 2 years of experience working with web-based Interactive Response Technology (IRT)
- Knowledge of Azure DevOps (TFS), MTM and Sharepoint preferred
- Competency with relational databases (SQL Server) and SQL
- Demonstrated knowledge of formal SDLC methodology and best practices
- Microsoft Office
- Bachelor’s Degree in Computer Science or Information Science related field.
- Knowledge of drug management
- Familiarity with 21 CFR Part 11 and other FDA regulatory requirements
- Basic familiarity with Object Oriented programming concepts and C#
- Experience using test management tools
- Automated test tool experience
- Knowledge of scripting languages
- Intermediate level SQL (query language) skills
- Knowledge of supply chain management
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Hybrid work available for applicable roles
- Professional development programs/ continuous learning opportunities