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.

The Quality Risk Management (QRM) Administrator is responsible for editing and assisting Subject Matter Experts (Quality Risk Register – Risk Owners) with the development creation, and of control of their appropriate Quality Risk Register Forms to comply with the new Quality Risk Register Procedure (TO SOP-0005). The QRM Administrator will partner with Risk Assessment Risk Owners to ensure that all required risk assessment requirements (Interim and Final Risk Assessment Reports) are controlled according to the Quality Risk Management Program per Procedure TO SOP-0019.

In addition, the QRM Administrator is responsible to perform any duties assigned by the QRM Lead as needed. These responsibilities could include the scheduling of risk methodology training sessions, COP meeting coordination's, verification of training attendance records and submission of required attendance records to the Quality Systems Training Department, and develop and maintain the quality risk website. Additionally, the QRM administrator will manage the risk assessment request forms, risk assessment status database, and risk review schedule, and coordinate with the risk owner any gaps that have been identified during the auditing of the risk assessments.

• 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 Shire 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.

• 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.

• 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.

For more information contact me