Experience

Biocomposites

• United Kingdom
• Medical Equipment Manufacturing
• 100 - 200 Employee

• • Jan 2018 - Present

  Resource for colleagues on matters concerning regulatory complianceOversee customer inquiries in accordance with the company’s unsolicited request policySupervise employee vendor credentialing program tasksAssist and, where appropriate take ownership of, CAPA activities impacting in the AmericasMonitor customer feedback and identify improvements where appropriateCoordinate appropriate training for office and field staff on compliance issuesPromote a culture that encourages ethical conduct and regulatory complianceCoordinate, in conjunction with Head Office, any necessary regulatory action (e.g. removals & corrections) liaising with FDA as requiredOversee QMS ImplementationParticipate in and/or perform QMS audits as required (including but not limited to 21CFR820, ISO 13485)Assist with registration activities in the Americas Show less

• • Apr 2017 - Jan 2018

• • Jun 2016 - Apr 2017

  Coordinate customer feedback reports by liaising with sales staff, distributors, hospital staff and departmental colleaguesCoordinate employee vendor credentialing program tasks Coordinate implantation of a Quality Management System to meet 21CFR820 & ISO 1348 requirementsPerform quality inspections of product inventory and document accordinglyAssist with employee training on company policies and proceduresAssist with internal and external audit activities as necessaryGeneral support for activities falling under the remit of the Compliance Department Show less



CastleBranch

• United States
• Human Resources Services
• 100 - 200 Employee

• Account Executive Support Specialist

  • Oct 2014 - Jun 2016

  Responsible for creating reports, researching and importing sales leads for Directors, Supervisors, and Account Executives utilizing Sugar CRM Compile data from IP PBX system Switchvox to generate a daily “Power Hour Report”, a sales initiative to improve performance for the Employment and Legal Screening Division Performed QC of company shared drive to eradicate brand no longer in use by document review Assist in development and preparation of Request for Proposals (RFPs) sent out by Sales Department as needed As a member of the Benefits Committee, responsible for obtaining vendors to participate in various corporate programs to drive employee engagement Coordinated the annual Brigade Boys and Girls Club's “Stuff the Backpack” campaign event for Sales Department Show less



PPD

• United States
• Research Services
• 700 & Above Employee

• Project Assistant

  • Nov 2013 - Apr 2014

  Review regulatory documents for the proper content in accordance with FDA, ICH/GCPs, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client Perform PPD investigator file reviews and log outstanding issues in project related tracking tools Liaise with clinical research associates and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner Develop and maintain assigned data points within the CTMS and Cascade databases according to the established conventions and tools for the project, within specified timelines Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments Show less



TranS1

• United States
• Medical Device
• 1 - 100 Employee

• Senior Commercial Operations Representative

  • Mar 2010 - Aug 2013

  Managed multiple product line training materials for Surgeon, Spine Consultant, Professional Education and Marketing trainings, conferences, and tradeshows Responsible for processing product Case Order Forms within Salesforce.com and inventory management system QAD for Spine Consultants and Distributors Developed corporate price lists and surgical pricing agreements with Spine Consultants and Director of Corporate and Strategic Accounts for the Sales Team Assisted R&D and Marketing departments on limited market release projects, capturing products used in surgeries and efficiently replenish for Alpha and Beta test group surgeons Trained Corporate Administrative Assistant on SAP Business One and Salesforce.com to assist Sales Department as needed Created standardized training material SOP documents for product lines to be utilized by Shipping department Developed in conjunction with IT, functionality within Salesforce.com to schedule training events that require product Redesigned training material space in warehouse for increased capacity of finished goods and raw components Executed product inventory cycle counting of finished goods and components in addition to reviewing and reconciling annual inventory counts submitted by Sales Team and Distributors Show less



TranS1, Inc.

• Wilmington, North Carolina Area

• Customer Care Representative

  • Jul 2006 - Mar 2010

  Designed process with marketing collateral site IMEC permitting Spine Consultants to create Surgeon Training Certificates upon validation by Quality Department Collaborated with IT to format Surgeon Training Database for cross departmental user-friendly access and maintained database with product training updates, report data to Finance and Professional Education departments Cross-trained additional Customer Care Representative to assist with Training labs, Surgeon Training Forms, and Surgeon Training Certificates Created and managed SOP documents ensuring Surgeon Training Certification guidelines achieved by surgeons prior to initial surgery Established par levels for non-sterile training components, reducing budget costs by recycling materials for future trainings Scheduled surgeries for Spine Consultants, process Case Order Forms via inventory management system SAP Business One Generated surgical instrumentation loaner requests for surgeries throughout Mid-Atlantic, South-East, Mid-South, West, and Mid-West territories including Puerto Rico; working with internal and external distribution facilities Produced orders for training materials, including Specimens and C-Arms for labs conducted throughout the US and International Show less



COVERBIND

• United States
• Retail Office Equipment
• 1 - 100 Employee

• Sales Representative - Reseller Department/Custom Cover Coordinator

  • Aug 2005 - Jul 2006

  Created sales materials for clients to facilitate the promotion of new products to end users Research and generate reports on potential areas of new sales for National Reseller Manager Responsible for quoting prospective custom projects for new and established clients Brief vendors on specifications of custom projects Final approval of artwork for projects prior to production Correlate with Production and Shipping Departments to ensure cost-effective delivery of stock and custom client orders Process sales orders for thermal binding solutions in inventory management system MFG Pro Show less