Integrated Resources Inc.
Senior Quality Compliance Specialist
Integrated Resources Inc., Wayne, Illinois, United States, 60184
A Few Words About UsIntegrated 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
Client: Direct ClientJob Title: Quality Compliance Specialist IIILocation: Wayne, PADuration: 7 Months + (Possible Extension)Job Summary:The Product Surveillance Specialist is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for pipe-line products and to deliver appropriate support in-line products enable a sustainable existence on the market. Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads and across Technical Operations and other functions / stakeholders across the Business to execute product quality surveillance strategies including but not limited to Product Quality Complaint handling, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions in to the post marketing surveillance.Responsibilities
Post Marketing Product Quality Surveillance:Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:Effective global Product Quality Complaint HandlingEffective global Product Annual / Periodic Product Quality ReviewSupport the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of SuppliersActive participation in team meetings, demonstrated ability to interact professionally and effectively with peers, management, and leadership both within and outside the department, within and outside the company, including regulatory agencies and business partners on a global basis.Must possess ability to work in a goal-oriented, time line driven, and dynamic work environment.Must be a well organized, self-motivated, and demonstrate an independent work style with the ability to initiate and follow through on goals and project schedules.Specifically the Complaint Specialist shall:Process global commercial / clinical product Quality Complaints receivedAssess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situationsLiaise with International Quality to ensure intake of appropriately redacted international complaint data is received assessed and processed and potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriatelyAssign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actionsPerform trend analysis on all incoming PQCs escalating to incidents and potential risks to managementCommunicate adverse events reported in conjunction with PQCs to PVRMFacilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection / investigationCoordinate pharmacy credits for returned product through Customer serviceCoordinate process and review PQC investigations performed at contract site manufacturer / packagers and site investigations in conjunction with Quality AssuranceEvaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriateGenerate final correspondence summarizing investigational findings and communicate via letter or fax to complainant / or communicate via the relevant international QA to ensure local communication requirements are met.Generate reports for management and inspections as requiredAssist as needed in the preparation of data for internal audits and external audits / inspectionsParticipate in third party call monitoring to ensure correct communication strategies are being utilized.Transition/ Integration support:The candidate will additionally support the transition and integration of legacy Product Quality Management quality systems for Complaints, Incident Management, APQR and Recall in to one solutions.Transition the ownership and processing of Complaints into PQM – execute a compliant transition, manage the SOP updatesSupport One Complaint system integration (One workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements)Support as needed:One APQR system integration and enhancements (workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements). Support in the delivery of the new Canadian YBPR requirementsSupport the PQM Product Quality System alignment into single One Quality SystemSupport change management of introduction of acquisition / integration / new products into and divestment of products out of the PQM Product Quality SystemsIntegration of One Recall and Withdrawal processesIntegration of One Board of Health Notification processesQualifications
Education and Experience Requirements:MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturingPrevious experience investigating and processing Product Quality Complaints required.The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.Internal and External Contacts:Internal contacts: PQM Leads, International Quality, North America Quality Assurance, Regulatory Compliance, Pharmaceutical Sciences, Global Pharmaceutical Technology, Global Regulatory Affairs.External contacts: Contract OrganizationsAdditional Information
Feel free to forward my email to your friends/colleagues who might be available.Thanks!!!Warm Regards,Amrit SinghClinical RecruiterIntegrated Resources, Inc.IT REHAB CLINICAL NURSINGTel: (732) 429 1634 (Direct)Ext: (732) 549 2030 x (212)Fax: (732) 549 5549http://www.irionline.com
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Client: Direct ClientJob Title: Quality Compliance Specialist IIILocation: Wayne, PADuration: 7 Months + (Possible Extension)Job Summary:The Product Surveillance Specialist is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for pipe-line products and to deliver appropriate support in-line products enable a sustainable existence on the market. Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads and across Technical Operations and other functions / stakeholders across the Business to execute product quality surveillance strategies including but not limited to Product Quality Complaint handling, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions in to the post marketing surveillance.Responsibilities
Post Marketing Product Quality Surveillance:Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:Effective global Product Quality Complaint HandlingEffective global Product Annual / Periodic Product Quality ReviewSupport the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of SuppliersActive participation in team meetings, demonstrated ability to interact professionally and effectively with peers, management, and leadership both within and outside the department, within and outside the company, including regulatory agencies and business partners on a global basis.Must possess ability to work in a goal-oriented, time line driven, and dynamic work environment.Must be a well organized, self-motivated, and demonstrate an independent work style with the ability to initiate and follow through on goals and project schedules.Specifically the Complaint Specialist shall:Process global commercial / clinical product Quality Complaints receivedAssess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situationsLiaise with International Quality to ensure intake of appropriately redacted international complaint data is received assessed and processed and potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriatelyAssign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actionsPerform trend analysis on all incoming PQCs escalating to incidents and potential risks to managementCommunicate adverse events reported in conjunction with PQCs to PVRMFacilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection / investigationCoordinate pharmacy credits for returned product through Customer serviceCoordinate process and review PQC investigations performed at contract site manufacturer / packagers and site investigations in conjunction with Quality AssuranceEvaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriateGenerate final correspondence summarizing investigational findings and communicate via letter or fax to complainant / or communicate via the relevant international QA to ensure local communication requirements are met.Generate reports for management and inspections as requiredAssist as needed in the preparation of data for internal audits and external audits / inspectionsParticipate in third party call monitoring to ensure correct communication strategies are being utilized.Transition/ Integration support:The candidate will additionally support the transition and integration of legacy Product Quality Management quality systems for Complaints, Incident Management, APQR and Recall in to one solutions.Transition the ownership and processing of Complaints into PQM – execute a compliant transition, manage the SOP updatesSupport One Complaint system integration (One workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements)Support as needed:One APQR system integration and enhancements (workflow design, user testing, training and education, GO Live and Hyper care / subsequent required enhancements). Support in the delivery of the new Canadian YBPR requirementsSupport the PQM Product Quality System alignment into single One Quality SystemSupport change management of introduction of acquisition / integration / new products into and divestment of products out of the PQM Product Quality SystemsIntegration of One Recall and Withdrawal processesIntegration of One Board of Health Notification processesQualifications
Education and Experience Requirements:MS or Bachelor’s degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturingPrevious experience investigating and processing Product Quality Complaints required.The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.Internal and External Contacts:Internal contacts: PQM Leads, International Quality, North America Quality Assurance, Regulatory Compliance, Pharmaceutical Sciences, Global Pharmaceutical Technology, Global Regulatory Affairs.External contacts: Contract OrganizationsAdditional Information
Feel free to forward my email to your friends/colleagues who might be available.Thanks!!!Warm Regards,Amrit SinghClinical RecruiterIntegrated Resources, Inc.IT REHAB CLINICAL NURSINGTel: (732) 429 1634 (Direct)Ext: (732) 549 2030 x (212)Fax: (732) 549 5549http://www.irionline.com
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