Randy Ruff Email & Phone Number

Venlo, Limburg, Nl

Deerfield, Illinois, Us

Manage the day-to-day operations within a functional area of Quality Assurance Documentation (QAD)Assess regulatory and quality risk within the regulated environment, in accordance with Baxter quality practicesProvides guidance to internal (quality partners) and external customers on documents and related systems.Indirectly manages personnel and encourages collaboration, teamwork and solidarityReceived BioScience Trainer Certification required to facilitate Baxter classroom coursesTrained and familiar with Six Sigma, 5S and Kaizen concepts Yellow Belt Certified.Department lead in management’s absencePrepared and presented QAD metrics at monthly Management Review Generated production records for GMP manufacturingServed as subject matter expert for the Baxter Product Lifecycle Management System (Document Management System)Updated course revisions and ran reports in ISOtrain (Learning Management System) Instrumental team member on Data and Documentation project – responsible for:o Providing input to create the project plan;o Ensuring all quality documents were retrieved from the document storage facility;o Negotiating the document storage vendor contract to termination;o Designing training on the Document Disposition Process for the entire Beltsville facility;o Designing a template and a process to inventory retained documentation:o Delivering customer service to departments

Us

Established & managed company archives (procured furniture & fixtures set up archive room)Served/Named as company’s ArchivistProvided the management for the training program (set up training files, issued training forms, filed completed records, etc)Provided the management for the controlled document processes including but not limited to, the release of all official documents, policed review, the approval process, editing and up dates.Provided the management for company’s official bibliography database (EndNote®), updating, article procurement and distribution.Developed and executed Access Databases (with reports) for:Controlled and released documentsToxicology/Pharmacology records and data reportsChemical Manufacturing Control (CMC) records and dataClinical Trial data – i.e. master files, and all study filesEquipment & Laboratory notebooks with one touch review abilityRegulatory records and data, New Drug Applications (NDA), Investigational New Drug (IND) Health Canada filings, (i.e. Clinical Trial Applications (CTAs))Assisted the Regulatory Department with FDA submissions both domestic and abroad

Managed Corporate Document Control DepartmentManaged one full time employee – provided direction, coaching, mentoring and development. Accountable for setting/achieving department goals and productivity, i.e. scheduled and executed departmental audits, new & changes to system/processes roll outs and establishing timelines.Accountable for department budget, i.e. equipment, furniture and fixture procurement.Corporate Document Control SpecialistAssisted in managing corporate wide Library of both hard copies and electronic documents.Supported the management of document life cycle i.e. submission, reviews, rewrites approvals and retirement.Prepared critical regulatory documents for FDA submission under auspice of Department Manager in pursuit of approval of OncoVax ® in US for commercial marketing. Interfaced with all sites, departments and levels of management in both US, The Netherlands and Switzerland.Conducted internal audits of Quality Assurance & Quality Control departments to ensure compliance.Contributed to the development, design and programming of database to streamline document management process while enhancing and creating a more robust system.