Drove process improvements, system integrations, change management, and validation efforts for FDA regulated computerized applications.• Lead the validation and deployment of ComplianceWire LMS. Coached stakeholders on training ideology and system use best practices.• Ensured maintenance of the validated state and optimal performance of five regulated systems.

Drove process improvements, system integrations, change management, and validation efforts for FDA regulated computerized applications.• Lead the validation and deployment of ComplianceWire LMS. Coached stakeholders on training ideology and system use best practices.• Ensured maintenance of the validated state and optimal performance of five regulated systems.• Coordinated with training content vendors and in-house resources to plan, budget, create, test, and deliver training materials in print, video, audio and SCORM formats.

Administered daily LMS operations and supported validation, implementation and change management for the training function. • Guided multiple departments in building their curricula and/or training ideologies with an emphasis on effective use of the LMS.• Created print and video training materials, supervised development of content creation by vendors.• Supported testing and validation of LMS integrations with SSO, HRIS, and EDMS systems.

Process improvement projects to expand LMS functionality and usability to current and new customers across the company. Contributions include:• Saved $14,000/year and reduced quarterly administrative burden by using Excel and PowerBI to create an automated, expandable LMS dashboard, KPI set, and reports.• Created automated training status and business intelligence dashboards to translate spreadsheet data into impactful, attractive, story-telling graphics for management and executives.• Automated and simplified the process to assign training, report on training metrics, and automatically notify trainers and management of training status for Learners at various learning milestones.• Created, beta-tested, and validated multiple LMS security roles for various stakeholders to perform system actions of differing complexity. Trained and supported six new administrators in these roles.

Managed and mentored a team of five LMS administrators on daily helpdesk operations, customer support, and help request processing.• Maximized process efficiency by negotiating formal service-level agreements between the technical support desk, LMS administration team, and customer base. This clarified roles and responsibilities within the process flow and standardized help request management and completion procedures.• Formalized LMS procedures through writing and deploying over 100 pages of new LMS Administration SOPs and work instructions.• Traveled to multiple domestic and international locations to provide hands-on to over 20 department administrators in curriculum design, management, and delivery.• Eliminated over 1000 hours of manual data entry by creating and deploying an electronic OJT program that required users to track and record their own training progress and completions directly into the LMS. This also eliminated the risks of ink-on-paper training documentation.

Supervised the LMS Administration team and drove training compliance and curriculum design through lateral and upward influence.• Trained five new LMS team members to triage and successfully process a highly visible backlog of over 2,300 help desk service requests (over 1050 hours of work) within six weeks.• Drove a 60% reduction in administrative workload for the LMS team through developing and implementing a simplified, electronic option for trainees and designates to upload completed training records directly into the LMS. Facilitated multiple training sessions to familiarize stakeholders with this new process.• Tackled inconsistent operations and tribal knowledge by formally documenting LMS administration procedures and then enforcing them with the LMS administration team.

Routed biopharmaceutical documents from creation, to revision, to implementation, to retirement. Responsibilities:• Edited content, layout, and technical formatting of SOPs, technical specifications, and other controlled documents, with an eagle eye for detecting and fixing inaccuracies.• Coordinated with customers to ensure accurate, efficient, and timely movement through the document lifecycle and project deadlines.• Created and revised customized documentation, binders, and bound logbooks to fit business and customer needs.• Maintained databases of documents, logbooks, pertinent controlled document information, and customer data to ensure accuracy and customer satisfaction.• Extensive use of Microsoft Word and Excel, and Adobe Acrobat, as well as other document management software.

Startup to steady-state initiative in cGMP wet process facility to manufacture soluble coffee used in Starbucks Via® and Frappuccino®. Delivered expertise in both wet and dry food processing techniques and equipment including:• Large-scale centrifugation• Large-scale high pressure and temperature brewing• Proprietary hot and cold brew concentration• Industry-standard powder drying techniques• QA benchtop analytical apparatus• Bulk-batch grinding of roasted coffee• Focus on safety, implementation of GMP/AIB compliance, autonomous maintenance, and troubleshooting.Additional deliverables included technical writing of new SOPs, job task analysis guides, and process theory training materials for the soluble coffee process and equipment. Specialized in creating materials that are concise, compliant, and easy to use and understand. Extensive use of Microsoft PowerPoint, Excel, and Word.

Facilitated New Hire Orientation class to introduce corporate culture and expectations to new associates. Learner engagement techniques included:• Encouraging participation by maintaining a welcoming, respectful, and safe learning environment• Audio and interactive visual presentation to engage auditory, visual, and kinesthetic learning intelligences• Lead by example to show respect for team members and classmatesClasses ranged from one to twelve learners of various ages, genders, ethnicities, and points of view. A preferred maxim to share with learners: "If you treat your job the way you would like to be treated, success will never be far behind".Past deliverables include printed training aids for store-level associates of skill levels from novice to experienced. Designed with a focus on job task efficiency, ease of use, and customer engagement.

Lead by example in the art and craft of selling custom, handcrafted beverages. Guided seven direct reports in achieving sales increases through meticulous customer engagement. Awarded in fall 2012 for motivating team to achieve top sales, in all of QFC, of a featured Starbucks beverage.Encouraged team members to take ownership of workspace and operations, and to suggest and try new methods of performing operations and administrative tasks for increased efficiency.Additional duties included inventory management, merchandise stock and presentation, and staffing interview, review, reward, guidance, and hiring/termination.

Delivered technical writing and database management in a highly visible, eleven month project to review and upgrade over 250 printed SOPs and batch records to accommodate implementation of new manufacturing execution system (SAP). Modernization of printed documents through:• Establishing and implementing an efficient and easy to use printed format with Microsoft Word and Adobe Acrobat that aligned with process flow on the manufacturing floor• Creating/owning a hardcopy checkout library and archive to monitor team progress and timeline adherence• Collaborating with technicians, operations management, QA, validation, process engineers, and technical writers to drive document lifecycle• Extensive database management using Microsoft Excel• Plenty of overtime and coffee, as neededDocument revision team exceeded expectations by submitting final drafts two weeks before deadline.

Executed multiple modes of large-scale column chromatography to isolate and purify medicinal proteins for multiple marketed and clinical biopharmaceutical drug products. Expertise in:• Anion exchange, hydrophobic interaction, size exclusion, various elution modes • Buffer solution preparation, titration and filtration• CIP (clean-in-place), SIP (steam/sanitize-in-place), COP (clean-out-of-place)• Sterile and aseptic technique• Benchtop conductivity, pH, and turbidity analysis• Focus on safety, quality, cGMP compliance, and application of innovative-yet-compliant troubleshootingIncreased cross-functional skill set in an intensive three month on-the-job internship in Process Validation group. Learned and executed surface soils and biological inoculation, equipment surface and coupon swabbing, fluorescent residue analysis, and pilot plant experimental equipment configurations. Additional deliverables included facilitating teams of trainees through the bioprocess technician training program, and mentoring existing team in pursuit of new equipment and process certifications. Included upgrading of various electronic and printed training materials for ease of use, compliance, and process relevance.