Project Coordinator

Project Coordinator

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Responsibilities for Quality Risk Management Administrator include:

• Help to set up and maintain Quality Risk Management SharePoint sites (Quality Risk Register and Quality Risk Assessment).
• Ensure consistent style and format for all Quality Risk Register and Risk Assessment documents (forms and periodic updates) in accordance with documentation and existing processes, and work instructions.
• Process all risk assessment procedures.
• Assist in the mapping and remediation with all Shire procedures mentioning risk.
• Identify and participate in documentation revisions of Quality Risk Register Forms, Risk Assessment Reports, QRM procedures and work instructions.
• Communicate deliverables for each Quality Risk Register and Risk Assessments action including follow-up and active communication on issues and potential roadblocks to appropriate parties (Risk Owners, Risk Owners Department Heads, Risk Champions, and other members referenced in the appropriate QRM documents).
• Maintain a list of Quality Risk Register actions as well as active and completed Quality Risk Assessments per QRM procedures and work instructions.
• Maintain the Quality Risk Register and Quality Risk Management SharePoint and Iris website.
• Participate in Quality Risk Register and Risk Assessment review, meetings and QRM work stream teams and communicate/manage input and feedback from team members.
• Manage the COP schedule.
• Support coordination of Quality Risk Management activities related to risk assessments and trainings.

Qualifications

Education and Experience Requirements

• Bachelor's Degree (or an equivalent combination of education and relevant experience).
• 5+ years relevant experience within a Quality Systems department in a cGMP environment. Knowledge of QRM principles would be extremely beneficial.

Key Skills, Abilities, and Competencies

• Strong written and verbal communication skills
• Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
• Must be very proficient with Microsoft Office applications, specifically Word and Excel.
• Basic understanding of SharePoint application.
• Ensure that the original information required within the various templates (QRR Form and other QRM applications) adhered to the requirements specified within the appropriate QRM documents.
• The ability to formulate thoughts (meeting action requests) and outstanding actions into periodic management updates and reports.
• Complexity and Problem Solving
• Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent's authority to make as well as those decisions that must be referred to a higher level.
• Support continuous improvement efforts to ensure QRM documentation is efficient and compliant
• Identify and analyze opportunities for process improvement. Verify that documents (Quality Risk Register forms) contain accurate details and instructions corresponding with the activity
• Ensure that the information contained in documents correspond with the information of related documentation.