Ann Marie Clock Email & Phone Number

Tucson, Arizona Area

Tucson, Arizona Area

20+ Years working with Manufacturing and Research implementing electronic documentation.

Global

Implementation and Administration of the QMS web-based electronic system for global business processes; training, and production support. Designed electronic forms for Supplier Management, Plant Trials, Non-Conformance Reporting, Material Review Board, Corrective and Preventative Actions, Management of Change, Contract Review, Project Management, and Manufacturing Audits. Oversight of user security and Document Control.Migrated QMS to new software in 2013. Oversaw configuration of new system, implementation and design of html forms.

Implemented and administration of the web-based electronic system for international business processes.Product – Medical Device - Total Artificial Heart and DriverSelected by the CEO of SynCardia in July 2005 to setup, validate, and train the personnel to maximize the use of the MasterControl electronic document software as the main element of change control. The use of this software encompasses the Device Master Record (specifications, drawings, and shop orders), Clinical Training (manuals, directions for use, contracts, and procedures), Administrative (job descriptions, accounting and human recourse, corporate policy and procedures), Marketing (press releases), Manufacturing (procedures), and Facility (preventative maintenance procedures and logs). Use of electronic forms to manage the Quality CAPA, MRB, NCR, and Customer Complaints. The Training module documents all internal training and verification. This system provided global access to the business process. In the 2007 case study published by MasterControl, Rodger Ford, CEO of SynCardia, stated that I had achieved "amazing results." The case study reports that I broke ALL time-line records for the implementation of this system.

Product – Nutrition and Sports SupplementsI was selected by the VP Quality and the VP Research of this nutritional supplements manufacturer to be responsible for the selection, formatting, and implementation of a FDA, GMP, and ISO 9000 compliant electronic document control system for seven divisions. This process included designing the company file storage, the validation of the software, overseeing the import of the files, the creation of easy to use product trees for the manufacturing floor, creating document approval routes, creation and oversight of user security, and the set up of Internet locations. Reduced the department budget by 50%, trained all corporate divisions, provided Internet access to documents, oversaw upgrade to FDA compliant versions, hardware/network and completed maintenance, and system audits. Achieved results of 30,000 files secured, 500 users trained. My department was responsible for the accuracy and synchronization of the ERP inventory control and cost accounting system with the documentation. Ensured that revisions were controlled, system was accessible to everyone, documents approved in days, immediate notification made to all departments, and tracking, accountability and history were accessible. Success in establishing this new department was the result of past responsibility for numerous departments and the continual education and training of employees. Reduced this department personnel from six to three employees and other department personnel from three to zero. Our department provided significant cost savings in reduction of personnel and the efficiency of manufacturing and purchasing processes. Total of 2,600,000 electronic documents stored.

Tucson, Arizona Area

Selected and implemented electronic document control software to meet Walmart supplier requirements.

Product – Invitro Clinical Diagnostic Test Kits for College of American PathologistsI was selected in by the CEO of this microbiology company to respond to the FDA Citation for Stability inaccuracies. I reported to the Vice President of Quality and the CEO. I chaired weekly Quality MRB and Audit reporting meetings. With a FDA expert I reviewed all systems. I was also the main interface with ISO auditor from Lloyd's Register Quality Assurance England. The ISO auditor utilized by far the most detailed approach I have experienced. Created and implemented supplier audit program. I completed regulatory compliance assignment in record time and within budget. Gull Labs was purchased by another company and moved from Utah to Ohio.

Product - Ceramic Oxygen Sensors and various research projectsSelected by this producer of oxygen sensors, analyzers and monitors, to create a newdocumentation department that would qualify the company for ISO-9000 Certification. *Established the company's first documentation control department. Organized documentationfrom 13 departments and consolidated them into one controlled area. Researched andselected an electronic document control system that reduced time required managing thesystem by 50%. * Organized the location, procedures and audit schedules that complied withISO, FDA and GMP guidelines. Scheduled trainers, set up groups, prepared data andfacilitated training of 100+ personnel on the electronic document control system. *Created visual aid work instructions for the manufacturing department using flow chartsand digital camera to train a multilingual work force. Wrote and photographed a quarterlynewsletter to share the mission of the Document Control Department, the focus of thedepartment's personnel and the positive changes brought about by management. * Coordinatedthe creation and implementation of a World Wide Web Homepage. This marketing toolincreased the visibility of products and product specifications, the company's mission,customer service efforts and answered frequently asked customer questions.

Product - Ceramic Oxygen Sensors, Fuel Cells, and various research projectsI managed the safety, health and environmental compliance of the research laboratories,manufacturing facility, and an administrative workforce of 120 employees. This includedthe development of policy, maintenance of MSDS files, training of personnel and thedistribution of training materials. * Established the first Safety Department for thishighly technical, 76,000 sq. ft. medical device manufacturing and research and developmentfacility. This program was reviewed and approved by the Utah OSHA. * Provided an extensivetraining and hazard assessment program for 13 departments that included safety auditing,respiratory fit testing and training, and revision controlled safety documentation. Thisresulted in significantly improved safety management, compliance with local, state andFederal regulations, and a more safety-conscious workforce. * Initiated an annual chemicalinventory program to comply with Hazard Communication. Created and facilitated 28 classesin safety management. I created visual aid work instructions for the manufacturingdepartment using flow chart and digital camera to assist multilingual employees. * Broughtfacility into compliance with the South Salt Lake City Water Department regulations byinstalling and maintaining a water sampling and back flow program. I oversaw the safety ofcompany vehicles for timely repair and maintenance.

Product - Ceramic Oxygen Sensors, Fuel Cells, and various research projectsI administered maintained and ensured compliance of a 76,000 sq. ft. and 5,000 sq. ft.manufacturing facility and research laboratories. I supervised three employees and abudget of $300,000 a year. * Managed two complex facilities and achieved total compliancewith all governmental regulations. I ensured proper inventory and storage of equipment anddocumentation. I managed furniture inventory and purchase. I created the FacilityMaintenance Schedule, Custodial Schedule and Check Lists to streamline operations. *Coordinated the repair of the primary water sprinkler main. Researched and selected a newwater vendor and saved $5,000 in yearly costs. In addition, I reduced water usageresulting in 30% water cost savings.

Product - Ceramic Oxygen Sensors, Fuel Cells, and various research projectsI created the Device Master for the product line that met GMP standards. With a staff oftwo permanent and two temporary employees and a budget of $250,000, responsible for allaspects of setting up this extremely detailed guide for the manufacture of 5,000 units ofproduct. * Purchased all materials to manufacture 5,000 units of product. Selected, hired,trained and supervised all personnel. I managed the transfer of the research process tomanufacturing. Held biweekly employee meetings to brain storm and discuss problems relatedto issues of assembly, coating, and design of fixtures, quality, and safety andscheduling.

Certification, Software Validation

Activities and Societies: Membership

Education record

Education record

Manufacturing, Document Systems, Research Support

Activities and Societies: My background allows me to understand what the end users requires to complete their responsibilities. Lab.

Education record