John Dampf Email & Phone Number

Smithfield, Nc, Us

Lincolnshire, Il, Us

• Interacted with Area Technical Specialists (ATS) to determine how spreadsheets should be updated.• Assisted the ATS group with developing and formatting spreadsheets/workbooks in Excel.• Navigated the Quality System process to submit and obtain approval for critical tools, workbooks, and spreadsheets.• Created Functional Requirements, Health and Risk Assessments, Training Plans, Test Suites and Test Summary Reports for Validation purposes.

Boston, Ma, Us

Client: Astellas Pharmaceuticals• Guided and advised authors and SMEs of procedures and other quality documents owned by the Medical & Development organization as they develop documents that drive compliance and global harmonization.• Assured that quality documents are aligned with the quality document architecture and standards.• Translated quality documents into process maps.• Reviewed multiple documents, and tracked common/differing elements to aid in harmonizing efforts.• Performed impact assessment of new, revised or obsoleted quality documents and complete related change request documentation.• Managed the change control process for new and revised quality document, and ensure appropriate stakeholder review and approval of quality documents.

Tokyo, Jp

• Supported the following departments: Quality Assurance, Pharmacovigilance (PV), Regulatory Affairs, Office of Ethics and Compliance, and Investigational Medicinal Products.• Worked with controlled document owners throughout the company to gather information to update and revise controlled documentation.• Was responsible for processing of all controlled documentation including but not limited to Policies, Standards, SOPs, Work Instructions, Forms, Templates, Specifications, User Manuals and References.• Managed the GMP training Requirements for the Investigational Drug department by keeping track of the employees training hours, hiring on-site GMP trainers, creating and maintaining a GMP training manual for employees to review to find off-site training. • Provided impact assessments of new, revised and archived controlled documents within our document management system. Also, advise the document owner on the action plan based on the outcomes of the impact assessment.• Managed the change control process for new and revised controlled document within the document management system which includes draft, review, approval, training issuance, archival and periodic review.• Ensured there is appropriate approval of the documents in the document management system.• Managed the electronic delivery of the training on new and revised controlled documents via the learning management system to appropriate personnel.• Created and publish all assessment tests with Articulate quizmaker to training portal.• Used SAP to issue and electronically deliver new and revised controlled document training requirements to all appropriate personnel.• Created multiple online training modules that were accessible throughout the company.

Tokyo, Jp

• Supported the following locations: TDC Americas, Europe, Asia and Japan regions.• Supported the QA functional area when preparing for internal and external audits and support the audits. Provided employee training records, archived copies of controlled documents and answer questions.• Conducted biennial review reports in the Document Management System and notify document owners with their documents are up for biennial review.• Issued new numbers to users when requested so they can create new QMS documents, forwarding document templates, assisted in formatting change over legacy controlled documents to QMS templates.• Used SAP to create qualifications, placing in master data catalog, assigning approver credit, updating training assignments by using reports.• Sented out email notifications to the LOCs, Asia, Europe, Japan, Vaccines, Boston and Americas so they know a new training requirement has been issued.• Queried training matrixes owners on new/revised documents to determine if the document should be assigned to their departments training matrices.• Created a Biennial Review process map so the other DTSs can use as a training aid when creating Biennial Review reports.• Reviewed documents submitted by authors by adding comments and providing input to the content.• Worked closely with QA Quality Systems department on waivers and deviations.

Tokyo, Jp

• Supported the following locations: TGRD US, Europe and Asia regions and TPNA (Takeda Pharmaceutical North America).• Designed and deliver training materials including instructor led training.• Leaded and facilitated meetings with SMEs from functional area teams to develop process maps, as well as create and revise procedure documents.• Collaborated with SMEs to design, develop, implement, and deliver (if appropriate) training based on creation and revision of procedure documents.• Identified appropriate training vendors. Negotiate contracts with vendors to develop customized course content. Evaluate internal processes, suggest process improvements, design/implement quality improvements, and create appropriate documentation.• Created a Filemaker Pro database to maintain our departments Training Matrix Control Form documentation.• Acted as liaison between QA&C Documentation and Training functional area and the other functional areas in the company.• Managed Training Matrix Change Control creations and revisions within our Learning Management System using SAP.• Supported the QA functional area when preparing for internal and external audits and supported the audits.

Indianapolis, Indiana, Us

• Worked with document owners throughout the company (Quality, Validation, Technical Services, EM, Sterility Assurance and Production) to gather information to create, update and revise FDA regulated procedures in a GMP manufacturing facility.• Facilitated redline meetings to encourage feedback and resolve conflicts with procedure revisions.• Routed procedures in NovaManage (Eli Lilly and Company document management system) for review and approval.• Created and revise technical illustrations to be used in procedures and training aids.• Captured, uploaded and edited photos (reduce size/edit format) to be used in procedures and training aids.• Created drawings to be used in procedures/training to illustrate key points.• Revised procedures by putting them in step action format, clean-up grammar and fix steps.

Indianapolis, Indiana, Us

Client: Eli Lilly and Company Pharmaceutical Company• Met with Subject Matter Experts to gather information to update and revise FDA regulated procedures.• Conducted redline meetings to encourage feedback and resolve conflicts with procedure revisions.• Created new procedures by working with Subject Matter Experts from departments.• Assisted in revising the parenteral operations Performance Improvement department Procedure on Procedures.• Facilitated redline and approval process of procedures within NovaManage document management system.• Revised and cleaned up illustrations in procedures.• Worked with a team of technical writers to create a new procedure structure that will be implemented throughout all parenteral departments.

• Developed Training and Performance manuals and workbooks for software applications.• Managed several projects in the Organizational Learning department. Working with both peers within the department and with additional personnel outside the department.• Created Authorware automated training courses used to test Transamerica employees, which reduced training time at least 70%.• Interviewed subject matter experts/team leads/managers to gather information to develop training material for jobs in the company.• Created online process maps and procedures for many departments within the company.

Client: CitiMortgage, Inc. • Facilitated training classes on software programs such as PowerPoint, Word, Excel, Access, Outlook and several mainframe programs created in-house.• Created an Access database that records and tracks all of the company's training.• Interviewed subject matter experts to gather information to develop software user guides.• Performed Quality Assurance testing on internally created programs.• Wrote training manuals and workbooks for various software applications.• Evaluated and recommended software packages for multimedia development and distance learning projects.• Utilized a variety of software including Robohelp to create help systems for in-house software programs.

Singapore, Singapore, Sg

Clients: Charleswood Furniture - Inland Fisher Guide - Wrightpaper- Necco-Tron - General Motors - MEMC- Nash Engineering Company - Continental Sprayer - Reckitt & Colman• Managed a team of trainers whose responsibilities were to train new machine operators on various machines within the plants. As the project manager I was required to design the training, coordinated the training, followed up with the training personnel, and make sure that each trainee was successfully trained.• Created training videos that demonstrate the proper way to operate all the machinery throughout the plant. When creating the digital video my responsibility was to create the scripts, record the audio voice-overs and video editing.• Designed several computer-based training courses used to teach employees the proper method to operate and set up the machines in the plants. The training reduced setup time by 65%.• Interviewed subject matter experts to gather information to be used in instruction manuals.• Developed instruction manuals for various machines throughout the plants. Each manual taught terminology, safety, setup, adjustments, troubleshooting, operation and maintenance of the machine. The instruction manuals reduced damage to the machines by 50%.• Tracked employee training to ensure all employees completed their required training.• Facilitated classroom and hands-on training on all machinery on the factory floor.• Implemented new training techniques that required collaboration with all levels of management.• Created technical illustrations (using both vector and pixel based graphics), which were used in the training manuals and job aids.• Conducted needs analysis to identify training opportunities to meet department and company goals.• Developed assessment evaluations to measure the effectiveness of training initiatives.