Almac Group is currently seeking a Software Testing Analyst 1 for our Lansdale, PA location. The Software Testing Analyst 1 will use formal software test methodologies to write and execute functional, system, performance, and usability/compatibility test plans and test cases for automated and manual tests related to products supporting a pharmaceutical clinical services organization. The individual will log errors, recreate them as needed, track errors through to resolution, and escalate issues when appropriate. The individual will create test reports and maintain significant levels of test documentation. The software testing analyst will ensure communication of project test status to project team members and will be responsible for the timely delivery of all test deliverables. Additional responsibilities will be to participate in requirements and system design and control the change management process for each assigned project.

QUALIFICATIONS:

Required Experience / Education:

• 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
• Some experience creating and implementing manual test suites in a formal SDLC environment
• Knowledge of Azure DevOps (TFS), MTM and Sharepoint preferred
• Familiarity with relational databases (SQL Server) and SQL
• Experience with formal SDLC methodology and best practices
• Microsoft Office

Preferred Experience / Education:

• 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

• 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