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Systems Analyst, Quality Data System

SUMMARY

This position is a technically oriented role and will perform as hands-on technical analyst and IT systems owner to provide IT operational support for all IT systems, solutions, and applications in support of Quality Operations.   Key responsibilities include:

  • Execute daily IT operations (e.g. configuration, administration, master data management, etc.) of all IT systems and services in scope.   Trouble-shoot and resolve Tier 2 through 3 tickets with vendors.
  • Author business and technical requirements
  • Execute efficient and effective operational IT processes that adapt to the dynamics of the business
  • Deliver to best practices in IT architecture, IT security, GxP compliance, and IT production operations.
  • Execute IT software development lifecycle (SDLC) methodology to deliver new solutions and system enhancements.    Follow IT GxP procedures.
  • Collaborate with Business Systems Owners and IT colleagues
  • Strong Partnership  with the Quality Organization

As IT owner of established systems, accountable to ensure such systems are fit-for-purpose for our business processes, and serve as main point of contact for escalation of any system issues, data integrations and system enhancements.  Participate in new systems implementations as business and systems analyst.  

 

RESPONSIBILITIES

  1. IT Operations (70%) - Provide hands-on operational support (technology, out-of-the-box configurations, process and content) for installed solutions.  Author GxP business and technical requirements, use cases, process flow document, create robust test plans and scripts, execute testing, support user acceptance testing, and perform production rollout.   Responsible for maintaining systems documentation, and adherence to IT Policies, SOPs, compliance standards, GxP requirements and change controls. Provide technical consulting and perform user training with Business System Owner as needed. 
  2. Business Partnering and Solutioning (10%) - Responsible for understanding business problem to be solved, the end-to-end business processes, dataflow and conditions.   Apply business process improvement methods to optimize business processes using best practices.
  3. Implementation (20%) – Provide support during new systems implementation process, overseeing development or configuration to ensure the solutions are built and will meet/exceed the needs of the business.   Own and create test plans, user acceptance tests, and coordinate training and roll-out.

 

QUALIFICATIONS & EXPERIENCE

  • Bachelor’s Degree in Computer Science/Information Systems related or equivalent experience, MBA or advanced degree desired
  • 5+ years of IT Operations role supporting Biotechnology or Pharmaceutical quality operations function, and experience in related packaged applications, systems, business process and IT process.
  • 5+ years hands on experience with GxP and regulated systems, including execution of IT computer systems validation deliverables and process
  • Demonstrated experience in IT systems operations, new systems implementation, and IT software development lifecycle
  • Proven ability to effectively own and support multiple systems
  • Strong cross-functional and IT analyst skills.
  • Strong process mapping ability, and ability to see the big picture
  • Technical experience (administration, configuration, meta-data management, etc.) with any or all of these quality oriented solutions:  Laboratory Information Management Systems, Environmental Monitoring/Controls, Document Management (Master Control), Manufacturing and Laboratory Investigations.
  • Highly energetic, passionate champion for the business and an ability to quickly establish credibility
  • Strong ability to identify/anticipate opportunities, problems and road blocks, maintains a solution focused approach and develops plans accordingly.
  • Ability to bring people together and communicate technical language in a non-technical manner.
  • Ability to communicate with individuals and groups about their needs, identify essential requirements and implement solutions.
  • Demonstrated hands-on experience creating business requirements, functional requirements, process maps, test plans, and test scripts
  • Ability to interact effectively as individual contributor or as a member of a team.
  • Able to work in a fast paced deadline driven environment.
  • Work on complex and abstract problems independently where decisions are based upon a mixture of analysis, wisdom, experience, judgment and rigorous logic and methods.
  • Meet deadlines and deliver quality work, even under pressure.
  • Cloud based software applications, packaged application, platform implementations, or custom development experience

                               

                                                               

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