Career Opportunities

Quality System Change Management Analyst II

Posted on: Tuesday, June 20, 2017
Organization: Ortho Clinical Diagnostics
Location: Raritan, NJ
Description:

The Career Potential:

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

The Opportunity:

The QS Change Management Analyst ensures the portfolio of changes are managed and aligned with the business and compliance objectives and prioritized accordingly. Participates in and may lead the change board. Responsible for managing standard changes through the lifecycle of the Change Process. The QS Change Management Analyst creates and monitors the change plan in partnership with the Change Sponsor by gathering cross functional inputs, designing the change plan, assessing the change risk/impact and driving the timely implementation in accordance with policies and procedures.

This position can be located in Raritan, NJ or Rochester, NY.

The Responsibilities:

Participate in Change Board and create template, fast track change plans along with Change Sponsor. Gather cross function inputs for the Change Plan based upon scope of change. Ensure timely, compliant change execution and implementation. Collaborates with global business partners, including technical experts and senior level change sponsors.

Support Change Management Associates in reviewing new change requests. Evaluate these new changes against business and compliance objectives to ensure the pipeline of changes are prioritized and have appropriate sponsorship.

Monitors the change process and reports overall status to leadership and through the Quality System Management Review. Proactively addresses issues impacting the Change Management Process and identifies process improvements and efficiencies which enable simple and streamlined implementation.

Utilizes the Ortho Global Training process to provide training to cross function associates on the Change process. Coaches and mentors business subject matter experts and change sponsors on the change process requirements to ensure consistent execution.

Requirements:

The Individual:

  • Minimum of a Bachelor’s degree in Science, Engineering, QA or other related business field or equivalent job experience.
  • A minimum of 2-4 years’ experience related to compliance processes in a regulated biologics, pharmaceutical and/or medical device environment is required with a preference for a background in the in vitro diagnostics (IVD) industry.
  • Expert knowledge in quality compliance and previous experience in global quality system expectations.
  • Experience implementing global changes required and experience supporting audits preferred.
  • Superior skills in MS Word, Excel, PowerPoint, Adobe, and database applications.
  • Works under general supervision.
  • Work is reviewed for soundness and technical judgment, overall adequacy and accuracy
  • Strong interpersonal and communication skills.
  • Able to maintain a high degree of confidentiality and professionalism and be able to successfully interact with individuals at all levels of the company
  • Up to 5% domestic and/or international travel.

Apply Now

View All Career Opportunities »

Career Opportunities

Quality System Change Management Analyst II

Posted on: Tuesday, June 20, 2017
Organization: Ortho Clinical Diagnostics
Location: Rochester, NY
Description:

The Career Potential:

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

The Opportunity:

The QS Change Management Analyst ensures the portfolio of changes are managed and aligned with the business and compliance objectives and prioritized accordingly. Participates in and may lead the change board. Responsible for managing standard changes through the lifecycle of the Change Process. The QS Change Management Analyst creates and monitors the change plan in partnership with the Change Sponsor by gathering cross functional inputs, designing the change plan, assessing the change risk/impact and driving the timely implementation in accordance with policies and procedures.

This position can be located in Raritan, NJ or Rochester, NY.

The Responsibilities:

Participate in Change Board and create template, fast track change plans along with Change Sponsor. Gather cross function inputs for the Change Plan based upon scope of change. Ensure timely, compliant change execution and implementation. Collaborates with global business partners, including technical experts and senior level change sponsors.

Support Change Management Associates in reviewing new change requests. Evaluate these new changes against business and compliance objectives to ensure the pipeline of changes are prioritized and have appropriate sponsorship.

Monitors the change process and reports overall status to leadership and through the Quality System Management Review. Proactively addresses issues impacting the Change Management Process and identifies process improvements and efficiencies which enable simple and streamlined implementation.

Utilizes the Ortho Global Training process to provide training to cross function associates on the Change process. Coaches and mentors business subject matter experts and change sponsors on the change process requirements to ensure consistent execution.

Requirements:

The Individual:

  • Minimum of a Bachelor’s degree in Science, Engineering, QA or other related business field or equivalent job experience.
  • A minimum of 2-4 years’ experience related to compliance processes in a regulated biologics, pharmaceutical and/or medical device environment is required with a preference for a background in the in vitro diagnostics (IVD) industry.
  • Expert knowledge in quality compliance and previous experience in global quality system expectations.
  • Experience implementing global changes required and experience supporting audits preferred.
  • Superior skills in MS Word, Excel, PowerPoint, Adobe, and database applications.
  • Works under general supervision.
  • Work is reviewed for soundness and technical judgment, overall adequacy and accuracy
  • Strong interpersonal and communication skills.
  • Able to maintain a high degree of confidentiality and professionalism and be able to successfully interact with individuals at all levels of the company
  • Up to 5% domestic and/or international travel.

Apply Now

View All Career Opportunities »