Systems Quality Associate

Department: Research and Development

Reports to: Director of Software Engineering

Status: Exempt

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: Perform the day-to-day software quality assurance tasks validating internal clinical trial computerized software in addition to third-party software. Also expected to identify, analyze, resolve and document problems as they arise in this FDA-regulated industry. This level is characterized by responsibilities of a mid- to senior-level individual with the ability to interact with Project Managers, CRAs, software developers and management. The individual requires minimal supervision and ongoing training in order to assure consistent performance.

Essential Functions

  • Draft Validation Plans, Test Scripts and Validation Reports to document validation activities in compliance with applicable regulations, including 21 CFR Part 11
  • Perform or support the execution of test scripts for clinical trial software modules
  • Write traceability matrices to ensure all user requirements have been tested
  • Research and isolate software defects
  • Clearly and concisely document defects and steps to consistently reproduce findings
  • Key contributor to quality systems development related to software validation
  • Support defect tracking database and verify that issues have been successfully resolved after being reported as fixed by development engineers
  • Identify problem areas within the individual trial configurations and work in conjunction with Project Managers to resolve them
  • Provide Quality Assurance review of clinical trial data changes

Qualification/Knowledge Requirements

  • 3-5 years experience in the development and management of test cases and test plans for use in testing FDA-regulated software
  • Experience with Windows operating systems, networks and Office Suite
  • Excellent organization skills
  • Excellent communication skills
  • Ability to multi-task and be detail-oriented

To apply, please submit your cover letter and resume to: careers@wcclinical.com
Fax: +1-513-352-9436


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Business Analyst

Department: Research and Development

Reports to: Director of Software Engineering

Status: Non-exempt

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: The business analyst is the liaison between the operations, technology and support teams. The business analyst understands the customer’s business requirements and business process management, and translates them to particular software requirements.

Essential Functions

  • Elicit requirements using interviews, document analysis, requirements workshops, surveys, business process descriptions, use cases, scenarios, business analysis, task and workflow analysis
  • Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying true needs
  • Proactively communicate and collaborate with external and internal customers to analyze information needs and functional requirements and deliver the following artifacts as needed: User and Functional requirements (Use Cases, Forms, Reports and User Interface designs)
  • Work independently with users to define concepts under direction of project managers
  • Drive and challenge business units on their assumptions of how they will successfully execute their plans
  • Strong analytical and product management skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements
  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
  • Serves as the conduit between the customer community (internal and external customers) and the software development team through which requirements flow
  • Develop requirements specifications according to standard templates, using natural language
  • Collaborate with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs

Qualifications

Basic requirements:

  • Minimum of Bachelor’s degree in Business Information Systems, Engineering or Computer Science
  • 2+ years of experience in a business systems analyst role
  • Strong project management, written and verbal communication and organizational skills

Desired qualifications:

  • Knowledge of clinical trial management
  • Knowledge of software guidance within GxP/FDA regulated industry
  • Self-motivated individual with strong interpersonal skills
  • Ability to manage multiple priorities and handle multiple projects simultaneously
  • Ability to quickly and effectively troubleshoot problems

To apply, please submit your cover letter and resume to: careers@wcclinical.com
Fax: +1-513-352-9436


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