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Change Specialist

In Minnesota / United States

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Change Specialist   

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JOB TITLE:

Change Specialist

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

St. Paul Minnesota / United States

JOB DESCRIPTION:

Change Specialist
Pay Rate: $21.94/HR


Cortech is seeking a Change Specialist in St Paul, MN.

The Change Specialist will lead and direct department employees to accomplish departmental goals, maintains workload balance, monitors incoming work levels to ensure timely processing of changes, communicates priorities and changes, and provides monthly metrics to the Supervisor/Manager for inclusion in monthly reports. The Sr Coordinator will accomplish this through ensuring the group
completes effective change request administration, properly applies configuration control concepts, provides technical
support to project teams as required, maintains controlled documentation and records, maintains documentation databases and ensures adherence to written documentation policies and procedures. Provide training and guidance to employees, identify and assist in resolving issues.

MAIN RESPONSIBILITIES
• Coordinate and control the processing of document and part changes, including delegation within Documentation Control and coordination and assignment of urgent changes.
• Monitor incoming change requests and ensures that changes are picked up and processed in a timely manner.
• Communicate business priorities to ensure high priority changes are managed to meet business objectives.
• Act as first point of contact for Documentation Specialists when questions/concerns arise.
• Provide training and coaching to Documentation Specialists.
• Assist in the coordination of the document control activities to meet departmental goals and project deadlines.
• Deliver Windchill training to users.
• Provide information and feedback, both positive and corrective, to Document Control Specialists based on communication from management or users.
• Coordinate implementation of change requests with all affected areas/facilities.
• Work with remote facilities/affected sites as necessary to assist in changes that affect multiple locations.
• Typically should spend 50% of time developing and leading Document Control Specialists and working on projects (may vary based on size of site and volume of work).
• Compile monthly data and submit to Supervisor/Manager for inclusion in monthly report.
• Maintain departmental procedures and update as required.
• Provide guidance and support to employees to understand documentation concepts and requirements.
• Be involved in testing of Windchill changes as requested.
• Keep departmental employees abreast of changes or updates to procedures as necessary.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems(QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Top skills:
Medical device experience regulatory, compliance, GMP
Knowledge of a documentation system
Technical writing

Position Details

POSTED:

Aug 02, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204861317159051

LOCATION:

Minnesota / United States

CITY:

St. Paul

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Change Specialist    Apply

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Change Specialist
Pay Rate: $21.94/HR


Cortech is seeking a Change Specialist in St Paul, MN.

The Change Specialist will lead and direct department employees to accomplish departmental goals, maintains workload balance, monitors incoming work levels to ensure timely processing of changes, communicates priorities and changes, and provides monthly metrics to the Supervisor/Manager for inclusion in monthly reports. The Sr Coordinator will accomplish this through ensuring the group
completes effective change request administration, properly applies configuration control concepts, provides technical
support to project teams as required, maintains controlled documentation and records, maintains documentation databases and ensures adherence to written documentation policies and procedures. Provide training and guidance to employees, identify and assist in resolving issues.

MAIN RESPONSIBILITIES
• Coordinate and control the processing of document and part changes, including delegation within Documentation Control and coordination and assignment of urgent changes.
• Monitor incoming change requests and ensures that changes are picked up and processed in a timely manner.
• Communicate business priorities to ensure high priority changes are managed to meet business objectives.
• Act as first point of contact for Documentation Specialists when questions/concerns arise.
• Provide training and coaching to Documentation Specialists.
• Assist in the coordination of the document control activities to meet departmental goals and project deadlines.
• Deliver Windchill training to users.
• Provide information and feedback, both positive and corrective, to Document Control Specialists based on communication from management or users.
• Coordinate implementation of change requests with all affected areas/facilities.
• Work with remote facilities/affected sites as necessary to assist in changes that affect multiple locations.
• Typically should spend 50% of time developing and leading Document Control Specialists and working on projects (may vary based on size of site and volume of work).
• Compile monthly data and submit to Supervisor/Manager for inclusion in monthly report.
• Maintain departmental procedures and update as required.
• Provide guidance and support to employees to understand documentation concepts and requirements.
• Be involved in testing of Windchill changes as requested.
• Keep departmental employees abreast of changes or updates to procedures as necessary.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems(QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS),Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Top skills:
Medical device experience regulatory, compliance, GMP
Knowledge of a documentation system
Technical writing


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