IT Quality Assurance Analyst: Exclusive

We are happy to exclusively present acontract opportunity with Kelly Services, Inc for an IT Quality Assurance Engineer servicing our client in Rochester NY, one of the most prestigious consumer & pharmaceutical manufacturers in the world.

Our client is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life.  The mission is simple yet powerful: Helping you see better to live better.

The IT Quality Assurance Engineer will advance and implement the Computer Systems Quality Assurance operating framework that aligns regulatory agencies compliance and the company’s quality expectations, business goals and objectives. 

The candidate will also be responsible to:

  • Ensure adherence to and continuous improvement of the System Development Life Cycle processes 
  • Provide day-to-day guidance and support to the computer systems validation team and interfacing with Program Managers and other team leaders 

Desired Qualifications:

  • 5+ years of experience in computer validation.
  • 5+ years hands-on experience with Software Quality in a GxP regulated environment; 
  • Experience with auditing Software Quality Management Systems 
  • Experience with leading successful teams, maintaining schedules, dealing with resource constraints, providing guidance, and with identifying and recommending changes to established practices 
  • Strong written and oral communication and interpersonal skills 
  • Good team player with ability to work independently and the SUPER POWER to Multi-Task!

Day to Day Overview:

  • Guidance and support Project Managers throughout the project lifecycle in the implementation, verification and validation of GxP and enterprise computer systems, its documentation to ensure compliance to Project, Internal and External requirements. 
  • Create and maintain Computer Systems Quality Assurance documentation for GxP and enterprise computer systems 
  • Improve Computer Systems Quality Assurance operating framework to include policies, SOPs (Standard Operations Procedures) WIs (Work Instructions) and reference documents to optimize usability and ensure successful Project and Internal and FDA audit results 
  • Facilitate System Development Life Cycle (SDCL) training classes that educate Project Managers and teams on Computer Systems Quality Assurance topics and ensure compliance with internal and external regulation and requirements. 
  • Collaborate efforts with the training team to ensure deployment of competency training specific to System Development Life Cycle (SDCL) 
  • Participate in Internal and Regulatory audits, as required 
  • Perform application remediation activities, as required 
  • Provide Project Management assistance, if required 
  • Maintain an effective Software System Lifecycle process through periodic assessments 
  • Promote and support Change Management Process 
  • Participate on project teams to assure the adequacy and compliance of Software Quality activities Ensure adherence to Best Practices and Industry Standards 

Additional Detail:

  • We appreciate all applicants, but we are not able to sponsor now; no C2C or H-1B. No third-party suppliers.
  • There is no ‘per diem’ with this position, and must be able to work on W-2 hourly basis.
  • There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.

This role is supported by the Kelly Services GTS – Recruiting and Sourcing division.  As your local offices do not support this position, for immediate consideration, please apply online to this posting directly AND send your current resume to JOET110@kellyservices.com

 

Why Kelly®?

With Kelly, you’ll have direct connections to leading IT organizations in the best companies around the globe—offering you the chance to work on some of today’s most intriguing, innovative and high-visibility projects. In a field where change is the only constant, our connections and opportunities will help you take your career exactly where you want to go. We work with 90 of the Fortune 100™ companies companies and found opportunities for more than 8,600 IT professionals last year. Let us help advance your career today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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