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PROFESSIONAL EXPERIENCEDiapharma Group, Inc. March Street Address   PresentWest Chester, OHQA/RA Manager September Street Address  - PresentRepresents Management Team during all internal and external audits.Promotes audit readiness and prepares company for audits by external bodies, including FDA and customers. Facilitates audits as needed.Assures compliance with FDA regulations.Generates and implements investigations and corrective action plans for deviations, internal audits and regulatory inspections.Owns and manages quality systems, processes, policies, and procedures to assure product quality and safety across the business.Reviews all procedures bi-annually to confirm compliance with FDA regulations and business goals.Owns noncompliance process and performs risk analysis review for all noncompliance documents.Creates and presents quality metrics presentation to Executive Management quarterly.Influences quality system metrics such as Corrective and Preventive Action and complaint resolution.Owns, manages and schedules preventative maintenance, calibration and repairs of all quality equipment. Performs inventory and functionality reviews of all quality equipment.Performs internal audits of website and restricted article process.Owns customer complaint system.Engages in strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs).Approves new and revised documents and website content.Maintains FDA registration, USDA permit, US government System for Award Management eligibility and Unique Device Identification Number (required by the FDA).Quality System Specialist March 2016  September 2019Managed Document Change Notification (DCN) process and documentation.Managed accounts payable process: created credits and invoices, contacted customers regarding overdue invoices and transferred payments when applied incorrectly.Ran back-order report weekly showing what products we have not received from our vendors.Managed trade shows. Ordered booth, furniture, floral arrangements and services. Instructed third party vendor what items to ship and where/when to ship them. Prepared shipments of items needed: cleaning supplies, tool kit, extension cords, office supplies, etc.Assisted in equipment maintenance and completed documentation. Assisted in quarterly equipment inventory reviews.Aided in noncompliance process and maintained documentation.Collected data and created the quality metrics presentation.Maintained Unique Device Identification Number required by the FDA.Paycor August 2015  March 2016Cincinnati, OHShared Services Support SpecialistImported and entered payroll information for client companies and employees within firm deadlines.Verified all necessary information and forms had been obtained by the client.Documented and communicated outstanding configuration issues to internal parties.Ensured all services were assigned to clients account.Recorded and maintained clients account status in project management software.Schulman Associates Institutional Review Board, Inc. September 2012  August 2015Cincinnati, OHStudy Change CoordinatorCommunicated board decisions to clients.Edited, collaborated, processed, prepared and finalized informed consent documents for clients.Participated in Ethics Review Board meetings.Offered suggestions on how to improve quality processes.Wrote notifications and letters relaying Board decisions to clients.Edited informed consent documents for client review.Processed and prepared final informed consent documents for the clients.Board Services CoordinatorCreated, revised and finalized Ethics Review Board meeting minutes.Prepared Minimal Risk Review minutes to be presented for the Ethics Review Board.Uploaded to SharePoint documents for Board review.Downloaded from SharePoint documents that the Board reviewed to appropriate staff folders.Prepared documents reviewed by Board members for the study file.Contacted clients for necessary information needed by the Board to complete review.Schulman Associates Institutional Review Board, Inc. April 2011 September 2012Cincinnati, OHQuality Assurance CoordinatorMaintained a central quality records database, ensuring data integrity and accessibility.Conducted internal audits of source documentation and meeting minutes.Provided ongoing suggestions for quality process improvement.Represented the organization in matters related to quality and process consistency.Aided in hosting external audits conducted by clients and regulatory agencies.Wrote follow-up reports in response to any findings from client and/or regulatory agency (such as the FDA) audits.Answered questions regarding regulatory requirements and guidelines from clients and staff.Goodwyn IRB October 2008  March 2011Cincinnati, OHQuality Assurance CoordinatorConducted error audits to see where the company needs to add quality control checks.Reviewed and approved site created advertisements.Wrote documentation of current processes to ensure consistency across the company.Identified areas in the current processes where quality control checks need to be created and implemented.Created quality control checks that are used by the entire company for all current processes.Medpace August 2006  September 2008Cincinnati, OHClinical Operations  Study Start-up CoordinatorDistributed, tracked, reviewed, and approved investigator trial master file (TMF) essential documentation at project start up.Interacted with the Sponsor, sites, the Central IRB and Medpace Team.Provided input on project related documents (Essential Document collection process, informed consent form, recruitment advertisements, et cetera).Trained and assisted CRAs on the collection of essential documentation.Reviewed documents submitted by CRA and forwarded to sponsor/central file.EDUCATIONBachelor of Science-Criminal Justice/Concentration in BusinessUniversity of CincinnatiCincinnati, OHADDITIONAL INFORMATIONMember of the Regulatory Affairs Professionals Society (RAPS).Completed a nine-course program and earned Regulatory Affairs Certificate: Medical Devices.Received Certificate of Completion of Medical Devices QSR Training.Completed CITI Program for the Protection of Human Research Subjects.Interned with the City of Cincinnati Prosecutors Office twice.Aided the City of Cincinnati Police Department in hostage negotiation training.