Description

Quality Systems IT Business Analyst II/III

Summary

POSITION DESCRIPTION

Our client's Information Technology department is seeking a talented Business Analyst to oversee all aspects of computer systems related to Quality Assurance. As the subject matter expert for Quality systems, you will serve as a functional resource and collaborate with the Manager of Business Technology for Quality Systems.

Responsibilities

Understanding the Quality Assurance business domain: In this role, you will be responsible for gaining a clear understanding of the Quality Assurance business domain, including QA documentation, quality systems, training, and compliance roles and processes. Your expertise will be vital in providing technical solutions for Electronic Quality Management Systems (QMS).

Recommendations and industry knowledge: You will provide recommendations to facilitate decision-making by maintaining awareness of industry trends and becoming well-versed in business needs. Additionally, you must have a working knowledge of industry best practices and regulations relevant to the assigned system(s).

Requirements gathering and consultation: Collaborating with internal clients, you will gather requirements and provide guidance on new automated systems. You will also be involved in identifying and evaluating systems and procedures for business solutions.

Strategic planning and project management: Working closely with the QA organization, you will develop business cases, evaluate opportunities for process and technology improvements through cost-benefit analysis, and contribute to the development of multi-year strategic roadmaps. Additionally, you will participate as an integral member of teams for system implementation projects, potentially taking on project management responsibilities for small projects.

Technical liaison and documentation: As the technical liaison between clients and vendors, you will ensure that technical solutions meet client needs and that vendors stay on track. You will also be responsible for drafting technical documentation, test protocols, and procedures for assigned system(s).

Application support and problem resolution: You will provide application support for validated applications, troubleshooting technical issues and managing problems through to resolution. Having a working knowledge of change management will be essential for this role.

Minimum Requirements

 

  • Bachelor's degree or equivalent qualification
  • 2-5 years of experience working with quality systems in either an IT or QA function, including proficiency in the use of electronic Quality Management Systems (QMS)
  • Practical knowledge and application of cGMPs, especially relating to quality assurance processes and procedures
  • Strong communication skills with the ability to effectively communicate with all levels of the organization
  • Understanding of industry standards, systems development lifecycle, and change management methodologies
  • Strong negotiation, collaboration, problem-solving, and analytical skills
  • Excellent verbal and written communication abilities

     

Preferred Qualifications

Though not mandatory, the ideal candidate would possess the following skills and experience:

 

  • Experience with IT project management methodologies

     

If you are a driven and knowledgeable Business Analyst seeking an opportunity to contribute to the success of our client's Quality Systems, we encourage you to apply.

Employment Type: Contractor

Key Skills
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