24 days old

GxP Business Analyst

Durham, NC 27709
  • Job Code

We have a one year renewable contract for a GxP Business Analyst with a client of ours in RTP, NC. Candidates must have GxP experience and experience with manufacturing processes. Senior Business Analyst (BA) to deliver high-quality requirements in a project. This Senior BA will follow PO&T IT methodologies for project governance, leverage BA tools & techniques to capture business and functional requirements, and use approved corporate documentation templates for SDLC maintenance. Projects span the applications and integration with source systems like DeltaV, PI, LIMS, OPM and manual feeds. The focus of the position is, but not limited to, the day to day management of, and the long term strategy and advanced process analytics projects.

The individual will:

- Work in a team and serve as tactical IT liaison to the business through building and fostering a partnership.

- Demonstrate strong understanding of the business area and its supporting technology as well as broad understanding of overall business unit.

- Ensure solution delivery meets business need and expectation through business requirement gathering.

- Gather and validate business needs to translate into requirements for technical team.

- Work with technical teams to develop technical requirements and solutions.

- Owns the lifecycle management and associated documentation package for the systems.

- Is accountable for projects throughout entire lifecycle; depending on scale and complexity may need input or guidance on critical decisions.

- Be proactive in identifying solutions or opportunities that can help improve Business processes.

- Be point of contact for business focused application questions and be able to identify and leverage resources across IT

- Model and enhance business process diagrams and other related models to capture business operations change requirements within defined opportunities or projects, modeling both current and future state, typically using a graphical BPA or business process modeling tool.

- Document or map business processes targeted for change via approved projects, both current and future state. Determine and document the impact of process changes for the process owner.

- Define the needed business cases with project team and process owner, defining business outcomes, including current baseline and future target metrics, such as leading and lagging indicators, and linking to strategic key performance indicators (KPIs). Document business requirements for system enhancements and collaborate with IT to ensure effective development and testing needed for successful solution deployment.

Business partnership and technology expertise

- The Ideal candidate will have demonstrated experience in manufacturing business process and systems leadership as they relate to advanced process analytics.

- The ideal candidate will be able to demonstrate a successful track record of assessing systems against corporate and regulatory requirements and driving change to ensure compliance in a GxP environment

- The ideal candidate will possess a fundamental understanding of the process analytics applications, hardware, and supported processes utilized in a GxP biopharmaceutical company

- The ideal candidate will be able to demonstrate a successful track record developing processes, SOP's, systems to support applications and equipment in a GxP environment

- Provide recommendations to address and resolve business issues, improve business processes and leverage opportunities

- Demonstrate strong understanding of data integrity, quality, and change management processes in a GxP, regulated environment.

- Be point of contact for business focused application questions and be able to identify and leverage resources across IT


- In collaboration with the business customer, utilizes broad business knowledge to proactively search for strategic technological solutions

- Exerts some influence on the overall objectives and long-range goals of the business area

- Builds and manages peer and management-level business relationship through achievement of results, accountable to schedule, and allocation of resources and meeting customer needs


- Collaborates cross functionally to drive initiatives to a successful conclusion

Decision Making

- Identifies and recommends process improvements

- Demonstrates ability to identify issues, independently resolves routine issues, escalates more complex issues to a higher level


- In depth knowledge of business functional area with strong understanding of business unit (Or if new to business area, shows strong learning agility to achieve in depth knowledge)

- Understands the technology offerings applicable to the business when assisting in the design of solutions

- Has knowledge of and utilizes software lifecycle methodologies


  • Information Technology

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GxP Business Analyst

Randstad Technologies
Durham, NC 27709

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GxP Business Analyst

Randstad Technologies
Durham, NC

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