GxP Business Analyst

  • location: Research Triangle Park, NC
  • type: Contract
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job description

GxP Business Analyst

job summary:
e have a 6 month renewable position for a Business Analyst with GxP experience for a client of ours in RTP, NC. GxP is a must have for this role.

Business Analyst (BA) to deliver high-quality requirements in a project. This 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 process analytics applications and integration with source systems like DeltaV, PI, LIMS, OPM and manual feeds.

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.

- 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, quality or supply chain business process and experience as how they relate to data 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 data 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

Impact

- 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

Scope

- 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

Knowledge

- 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

Qualifications

Minimum Requirements:

- B.S. degree (in science, engineering or business), with related business discipline experience.

- 3 - 4 Years of experience as a Business Analyst

- Hands-on experience with process modeling, analysis and simulation tools.

- Track record of working on projects that delivered different types of business outcomes: revenue growth and customer satisfaction, for example, not just process efficiency or cost reduction.

- Manufacturing experience with knowledge of GMPs, GDPs

- Good interpersonal, verbal and written communication, including good presentations.

- Strong analytical and conceptual skills.

- More interested in business results than personal preferences, and in group rather than individual achievement

- Ability to work within high-performing virtual teams and highly collaborative

- Builds excellent relationships with key internal and external customers based on trust and confidence

- Minimum travel both domestically and internationally

- Supplement the Vendor management team focused on driving value and mitigating risk in vendor contracts and relationships

- Execute best practices and processes for managing technology suppliers and vendors, with focus on performance of Hardware, Software and Software as a Service providers

- Work with IT and TBS business partners to identify licensing and contract structure options, negotiate and support agreement execution against strict timelines

- Support vendor lifecycle activities as required - renewals, cost optimizations, growth.

- Identify opportunities to optimize vendor execution and relationships in support of organizational goals

 
location: Durham, North Carolina
job type: Contract
work hours: 9am to 6pm
education: Bachelors
 
responsibilities:
e have a 6 month renewable position for a Business Analyst with GxP experience for a client of ours in RTP, NC. GxP is a must have for this role.

Business Analyst (BA) to deliver high-quality requirements in a project. This 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 process analytics applications and integration with source systems like DeltaV, PI, LIMS, OPM and manual feeds.

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.

- 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, quality or supply chain business process and experience as how they relate to data 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 data 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

Impact

- 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

Scope

- 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

Knowledge

- 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

Qualifications

Minimum Requirements:

- B.S. degree (in science, engineering or business), with related business discipline experience.

- 3 - 4 Years of experience as a Business Analyst

- Hands-on experience with process modeling, analysis and simulation tools.

- Track record of working on projects that delivered different types of business outcomes: revenue growth and customer satisfaction, for example, not just process efficiency or cost reduction.

- Manufacturing experience with knowledge of GMPs, GDPs

- Good interpersonal, verbal and written communication, including good presentations.

- Strong analytical and conceptual skills.

- More interested in business results than personal preferences, and in group rather than individual achievement

- Ability to work within high-performing virtual teams and highly collaborative

- Builds excellent relationships with key internal and external customers based on trust and confidence

- Minimum travel both domestically and internationally

- Supplement the Vendor management team focused on driving value and mitigating risk in vendor contracts and relationships

- Execute best practices and processes for managing technology suppliers and vendors, with focus on performance of Hardware, Software and Software as a Service providers

- Work with IT and TBS business partners to identify licensing and contract structure options, negotiate and support agreement execution against strict timelines

- Support vendor lifecycle activities as required - renewals, cost optimizations, growth.

- Identify opportunities to optimize vendor execution and relationships in support of organizational goals

 
qualifications:
e have a 6 month renewable position for a Business Analyst with GxP experience for a client of ours in RTP, NC. GxP is a must have for this role.

Business Analyst (BA) to deliver high-quality requirements in a project. This 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 process analytics applications and integration with source systems like DeltaV, PI, LIMS, OPM and manual feeds.

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.

- 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, quality or supply chain business process and experience as how they relate to data 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 data 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

Impact

- 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

Scope

- 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

Knowledge

- 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

Qualifications

Minimum Requirements:

- B.S. degree (in science, engineering or business), with related business discipline experience.

- 3 - 4 Years of experience as a Business Analyst

- Hands-on experience with process modeling, analysis and simulation tools.

- Track record of working on projects that delivered different types of business outcomes: revenue growth and customer satisfaction, for example, not just process efficiency or cost reduction.

- Manufacturing experience with knowledge of GMPs, GDPs

- Good interpersonal, verbal and written communication, including good presentations.

- Strong analytical and conceptual skills.

- More interested in business results than personal preferences, and in group rather than individual achievement

- Ability to work within high-performing virtual teams and highly collaborative

- Builds excellent relationships with key internal and external customers based on trust and confidence

- Minimum travel both domestically and internationally

- Supplement the Vendor management team focused on driving value and mitigating risk in vendor contracts and relationships

- Execute best practices and processes for managing technology suppliers and vendors, with focus on performance of Hardware, Software and Software as a Service providers

- Work with IT and TBS business partners to identify licensing and contract structure options, negotiate and support agreement execution against strict timelines

- Support vendor lifecycle activities as required - renewals, cost optimizations, growth.

- Identify opportunities to optimize vendor execution and relationships in support of organizational goals

 
skills: e have a 6 month renewable position for a Business Analyst with GxP experience for a client of ours in RTP, NC. GxP is a must have for this role.

Business Analyst (BA) to deliver high-quality requirements in a project. This 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 process analytics applications and integration with source systems like DeltaV, PI, LIMS, OPM and manual feeds.

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.

- 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, quality or supply chain business process and experience as how they relate to data 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 data 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

Impact

- 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

Scope

- 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

Knowledge

- 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

Qualifications

Minimum Requirements:

- B.S. degree (in science, engineering or business), with related business discipline experience.

- 3 - 4 Years of experience as a Business Analyst

- Hands-on experience with process modeling, analysis and simulation tools.

- Track record of working on projects that delivered different types of business outcomes: revenue growth and customer satisfaction, for example, not just process efficiency or cost reduction.

- Manufacturing experience with knowledge of GMPs, GDPs

- Good interpersonal, verbal and written communication, including good presentations.

- Strong analytical and conceptual skills.

- More interested in business results than personal preferences, and in group rather than individual achievement

- Ability to work within high-performing virtual teams and highly collaborative

- Builds excellent relationships with key internal and external customers based on trust and confidence

- Minimum travel both domestically and internationally

- Supplement the Vendor management team focused on driving value and mitigating risk in vendor contracts and relationships

- Execute best practices and processes for managing technology suppliers and vendors, with focus on performance of Hardware, Software and Software as a Service providers

- Work with IT and TBS business partners to identify licensing and contract structure options, negotiate and support agreement execution against strict timelines

- Support vendor lifecycle activities as required - renewals, cost optimizations, growth.

- Identify opportunities to optimize vendor execution and relationships in support of organizational goals


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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