Software Quality Assurance (SQA) Associate - Boston, MA | Biospace
Get Our FREE Industry eNewsletter

Software Quality Assurance (SQA) Associate

WorldCare Clinical, LLC

Boston, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Trial, Quality Assurance,

Job Description

Expectation for all Employees

Support the organization’s mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, commitment to our community, and accountability and ownership.

Job Summary

Conduct day-to-day software quality assurance assignments of internal and out-sourced software development activities for clinical trial operations.  This encompasses all clinical trials within the company.  Identifies and resolves problems as they arise.  

This level is characterized by responsibilities of an individual with the ability to interact with Project Managers, Software Developers and management.  
The SQA Associate shall be very detail-oriented, possess good documentation skills, and be a self-starter.  The candidate will be capable of working with the software development engineers, software developer consultants, software developer contractors and clinical operations staff members to identify, isolate, and resolve defects found during all phases of the software product’s test cycle.  Shall demonstrate consistent and cooperative service in support of staff, co-workers, and sponsor personnel.  Must exhibit and maintain a team approach and a positive attitude.  
Essential Functions
• Support the development of detailed User Requirement Specifications, and Functional and Design Specifications as applicable.
• Responsible for developing detailed validation plans to cover the testing strategy, intended use of application, validation and functional risks, and the planned validation activities.
• Responsible for creating test cases and scripts to adequately verify that the software is performing as intended.
• Responsible for creating Requirements Traceability Matrixes to ensure that all requirements have been adequately tested.
• Responsible for developing detailed validation reports covering the results of the validation activities and any issues identified.
• Responsible for automated testing as appropriate.
• Effectively manage the issue tracking system.  
• Ensure that issues are documented and resolved in the issue tracking system in a timely manner.  
• Responsible for ensuring that software applications are develop and deployed with the ability to comply with 21 CFR Part 11, Electronic Records; Electronic Signature and Annex 11: Computerised Systems, EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, GMP Medicinal Products for Human and Veterinary Use
• Coordinates procedural or system changes with the Head of Q/RA, who has oversight of this function for Regulatory compliance, to improve the effectiveness of the quality assurance system.



• Bachelors in Computer Science degree or equivalent
• Experience with Windows operating systems and networks
• Excellent organization skills
• Excellent communication skills
• Excellent attention to detail