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Spirit Gathering
Consultant Manufacturing and Process
Ann Marie Clock
Manufacturing, Process, Validation, Electronic Documentation Consultant
cGMP FDA ISO Nutritional Supplements Software Validation Implementation Consumer Service Customer Service Information Systems Manufacturing Research and Development Electronic Documentation Environment Friendly 21 CFR Part 11 Quality Assurance Regulatory Compliance Medical Device Electronic Document Software Culture Change Revision Control Positive Results Microbiology Training Records Professional Sales Purchasing Quality Control Document Control Software Audits Supplier Certification Success Story Cost Effective Technology Quality Assurance Logistics Financial Records
Ann Marie Clock
Tucson, Arizona
E-mail:clock1976@comcast.net
Seeking a consulting position that will capitalize on my technical expertise and administrative background in…
ELECTRONIC DOCUMENT SYSTEMS
Budgets & Expense Control, Manufacturing Process, Documentation Control & Distribution ·GXP, cGMP, GLP, MRP, FDA, ISO & Guidelines, Supervision, Validation Compliance, Quality Assurance, Personnel Administration & Training, Documentation Creation, Regulatory, Manufacturing, R&D Senior Manager Business Process - SynCardia Systems, Inc.
In 2005 SynCardia received the FDA release of the only total artificial heart in the world. The CEO understood that quality business systems are the foundation of a successful company. Selected by the CEO of SynCardia in July 2005 to setup, validate. and train the personnel to maximize the use of MasterControl electronic document software as the main element of change control. The use of this software encompasses the Device Master Record (specifications, drawings, shop orders), Clinical Training (manuals, directions for use, contracts, procedures), Administrative (job descriptions, accounting and human resource, corporate policy and procedures), Marketing (press releases), Manufacturing (procedures), Facility (preventitive maintenance procedures and logs). Use of MasterControl electronic forms to manage CAPA, MRB, NCR, ESOP, and Customer Complaint. The Training module documents all internal training and verification.
DIRECTOR DOCUMENT MANAGEMENT Weider Nutrition International
Selected in March of 1998 by this manufacturer of nutritional supplements to be responsible for the selection, formatting, and implementation of a FDA, GMP, and ISO 9000 compliant, electronic document control system for multiple 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, a history of document routes and approval, and the set up of Internet locations for the company documentation. Reduced the department budget by 50%. As part of the presentation and training for the Weider Nutrition International Electronic Document Control system for all corporate divisions, I established the Vision, the Requirements/Research, the Selection/Purchase of Software, the Installation/Administration of Training, the Setup of the System, the Input of Documentation and the Implementation. ¨ Later, for the Roll-Out, designed and implemented a division and departmental training, Internet access to documents, an organizer setup, upgrade/FDA compliant versions, hardware/network upgrade, maintenance and system audits.
Achieved results of 30,000 files secured, 500 users trained. Department responsible for the accuracy and synchronization of the 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.
Financial software Administrator responsibilities given in 2002. Scanned from the records department the Bill of Lading's, Invoices, Purchase Orders, Credits, Voucher, Journal entries, etc are scanned to allow access to applicable users. Electronic system saves many hours researching and is extremely efficient.
Currently 2,600,000 electronic documents stored.
QUALITY AUDITOR, GULL LABS 1998 Selected in 1998 by this microbiology company to audit all processes and to respond to the FDA Citation for Stability inaccuracies. Reported to the Vice President of Quality and the CEO. Gull Labs produced a variety of invitro clinical diagnostic test kits and produces reference kits for the College of American Pathologists. Headed weekly 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. Gull Labs was purchased by another company and moved out of state. DOCUMENT CONTROL SPECIALIST, Ceramatec, Inc. Selected in 1996, by this producer of oxygen sensors, analyzers and monitors, to create a new documentation department that would qualify the company for ISO-9000 Certification. · Established the company's first documentation control department. Organized documentation from 13 departments and consolidated them into one controlled area. Researched and selected an electronic document control system that reduced time required managing the system by 50%. · Organized the location, procedures and audit schedules that complied with ISO, FDA and GMP guidelines. Scheduled trainers, set up groups, prepared data and facilitated training of 100+ personnel on the electronic document control system. · Created visual aid work instructions for the manufacturing department using flow charts and digital camera to train a multilingual work force. Wrote and photographed a quarterly newsletter to share the mission of the Document Control Department, the focus of the department's personnel and the positive changes brought about by management. · Coordinated the creation and implementation of a World Wide Web Homepage. This marketing tool increased the visibility of products and product specifications, the company's mission, customer service efforts and answered frequently asked customer questions. SAFETY ADMINISTRATOR Ceramatec, Inc. Selected in 1992 (and continued the assignment to 1997) to manage the safety, health and environmental compliance of the research laboratories, manufacturing facility and an administrative workforce of 120 employees. This included the development of policy, maintenance of MSDS files, training of personnel and the distribution of training materials. · Established the first Safety Department for this highly technical, 76,000 sq. ft. medical device manufacturing and research and development facility. This program was reviewed and approved by the Utah OSHA. · Provided an extensive training and hazard assessment program for 13 departments that included safety auditing, respiratory fit testing and training, and revision controlled safety documentation. Resulted in significantly improved safety management, compliance with local, state and Federal regulations, and a more safety-conscious workforce. · Initiated an annual chemical inventory program to comply with Hazard Communication. Created and facilitated 28 classes in safety management. Created visual aid work instructions for the manufacturing department using flow chart and digital camera to assist multilingual employees. · Brought facility into compliance with the South Salt Lake City Water Department regulations by installing and maintaining a water sampling and back flow program. Oversaw the safety of company vehicles for timely repair and maintenance. FACILITY ADMINISTRATOR Ceramatec, Inc. Selected in 1993 (to 1996) to administer, maintain and ensure compliance of a 76,000 sq. ft. and 5,000 sq. ft. manufacturing facility and research laboratories. Supervised three employees and a budget of $300,000 a year. · Managed two complex facilities and achieved total compliance with all governmental regulations. Ensured proper inventory and storage of equipment and documentation. Managed furniture inventory and purchase. Created the Facility Maintenance Schedule, Custodial Schedule and Check Lists to streamline operations. · Coordinated the repair of the primary water sprinkler main. Researched and selected a new water vendor and saved $5,000 in yearly costs. In addition, reduced water usage resulting in 30% water cost savings. QUALITY ASSURANCE MANAGER Ceramatec, Inc. Selected in 1991 (to 1992) to create the Device Master for the product line that met GMP standards. With a staff of two permanent and two temporary employees and a budget of $250,000, responsible for all aspects of setting up this extremely detailed guide for the manufacture of 5,000 units of product. · Purchased all materials to manufacture 5,000 units of product. Selected, hired, trained and supervised all personnel. Managed the transfer of the pilot line to manufacturing. Held biweekly employee meetings to brain storm and discuss problems related to issues of assembly, coating, design of fixtures, quality, safety and scheduling. Earlier career position…1989-1990, Lab Manager, EPH, Engineering Worked closely with the Ceramic Engineer in the testing of new and existing formulas and equipment. Set up a new laboratory. Tested water and solvent base ceramic formulas. Researched and ordered materials. Wrote procedures. Maintained inventory on all chemicals and materials. Kept safety files and organized data on all projects. ADDITIONAL CAREER INFORMATION
Member of the Institute of Validation Technology, Quality Auditor, Certificate ISO Internal Auditing and Documentation 9001,Certificate SQC, SPC, and DOE Certificate, Advanced Safety Certificate, Access 2000 Intermediate Certificate, Business Processing Certificate. Industries: Nutraceutical, Medical Device, Microbiology, Technical Ceramics, Guest Speaker - San Francisco Area ASQ Biomedical Discussion Group Designing Document Control Systems 11/2000
