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Work Background
ValidantSenior Consultant
Aug. 2022 - May. 2023Senior Quality Consultant for medical device company requiring re-design of internal quality systems. Responsible for business strategy of assessing current to future state operations. Development and facilitation of onsite kaizen events for cross-collaborative and holistic solutions. Primary duties: creating process maps, analysis and connection of gaps to regulatory requirements, cross-departmental needs analysis meetings, and providing direction Quality System operations.
Endo PharmaceuticalsSr. Quality Systems Specialist, Training
Nov. 2019 - Aug. 2022Rochester, MichiganSr. Quality Specialist responsible for administration of the ComplianceWire LMS, implementation of new electronic systems, curricula development and cGMP training. Strong management interface. Skills/expected duties: troubleshooting LMS administration, identifying training compliance issues/trends, and developing departmental training modules. Collaborative partner, facilitator, leadership development specialist and quality mentor. Skilled application of needs-analysis and relevant quality and system tools for problem solving and investigation activities.
ValidantConsultant
Apr. 2016 - Jun. 2016Consultant engaged to remediate pharmaceutical and medical device training programs. Completed multiple assignments with clients both domestically and internationally (Budapest, Hungary). Project Lead responsible for managing a $1.8 million dollar budget, developing formal charter and project plan, harmonizing doc control and training activities, conducting train-the-trainer sessions and reporting weekly progress to senior level stakeholders. Coach and mentor staff for increasingly complex training and change management strategies to maintain compliant and efficient operations. • Strong client-facing expertise.
• Curricula planning, analysis of client needs for large-scale remediation projects.
• Establish learning competencies for multi-division organizations.
• Author site policy and procedures for training program.
• Configure new and revised training curriculum into existing learning management systems.
• Strong project management, project planning and project integration skills.
ALKU TechnologiesQuality SME/Consultant
Nov. 2015 - Apr. 2016San Francisco Bay AreaConsultant for Thermo Fisher Scientific, a multi-national medical device company with over $17 billion in revenue. Responsible for development of curricula materials to support newly implemented QMS initiative. Primary duties: creating training content, conducting cross-departmental needs analysis meetings, and facilitating training for new Quality System. • Interviewed and analyzed departments to aid in design of current process workflows.
• Integrated Quality System tools into methodology for systemic implementation.
• Compared and analyzed existing operating procedures against revised and new business process.
• Made recommendations for streamlined training process controls for compliance.
• Developed current and future workflow strategies to reflect changes in technology.
PL DevelopmentsTraining Manager
Apr. 2012 - May. 2014Lynwood, CADirector level professional for mid-sized pharmaceutical organization of cough and cold products. Developed and implemented comprehensive organizational training program: established learning competencies, created database for records management, initiated compliance-based learning programs. • Oversight of training operations at East and West coast facilities. • Managed infrastructure development for multi-site training operations.
• Managed cGMP training operations, resulting in organized administration of a 400-person facility.
• Developed multi-departmental team of qualified trainers by facilitating Train-the-Trainer content.
• Provided direct training management for 85 qualified trainers.
• Implementation of comprehensive training program for East & West Coast facilities.
• Developed training database, netting high level reporting of statistics & trending metrics.
Dendreon CorporationSr. Quality Assurance Associate II - Training
Jan. 2010 - Dec. 2011Seal Beach, CASenior Training Management Professional for cancer therapy manufacturer. Managed cGMP training operations, resulting in FDA approval of new manufacturing facility. This included direct training of all internal and visiting Associates for compliance-mandated content. • Performed audits of exception/deviation data, leading to support of compliance driven directives.
• Ensured cGMP training compliance of current and revision SOPs by validating training plans.
• Tracked/trended deviations, non-conformances, corrective actions, OOS, and change controls. • Provided value added reporting and metric analysis of training data.
• Managed on-site implementation of validated systems for Doc Control & exception reporting. • Mentored and provided support for new trainers and training staff.
GrifolsSr. Trainer
Apr. 2007 - Oct. 2010Greater Los Angeles AreaSr. Trainer and Project Manager for an international plasma collection and processing organization. Collaborative partner in the development of safe and effective blood and plasma therapies, processing methods, and utilizing FDA regulated compliance guidelines. • Project Manager of leadership training initiative – executed training rollout for 500 employees.
• Facilitated leadership development training sessions for management and senior executives
• Provided cGMP training for manufacturing personnel. • Coordinated development of leadership content in alignment with employee competencies.
• Managed and facilitated annual re-qualification training of 500 staff in week-long, multiple shifts. • Conducted new hire compliance training on FDA regulations and quality systems.
• Designed curricula for training programs (technical, leadership, new hire, computer, compliance).
Kaiser PermanenteConsultant / Trainer
Jan. 2005 - Dec. 2007Greater Los Angeles AreaAssisted with successful deployment of electronic medical record (EMR) system in multiple departments of the Southern California region. • Operational planning and development of client needs for hospital implementation.
• Incorporated business processes/work flow strategies for integration into training sessions.
• Tracked and managed updates in training environment against live, production environment.
• Provided Epic Ambulatory training (Instructor-led) to S. CA Kaiser Permanente Medical Group.
• Provided client support of application during scheduled, go-live rollouts.
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