Timothy O'Brien Email and Phone Number

• Seamlessly managed workflow for SWFQ within an ISO 7 Class 10,000 clean room to achieve an unparalleled 100% on-time delivery rate, epitomizing the embodiment of dedication and ownership in driving optimal results• Fostered a culture of employee engagement and satisfaction by initiating process improvements, encouraging open communication, and providing growth opportunities, leading to higher team morale• Successfully reconciled over $40 million in inventory spanning 2K+ parts in SAP by spearheading the design of a dashboard in Microsoft Excel for monitoring audits and implementing optimal solutions to mitigate future risks, leading to enhanced SLA performance and KPI status in an FTZ environment• Led cross-functional meetings and exercised decisive judgment as QA representative, overseeing CAPAs and change controls to significantly decrease instances of Left Behinds and minimize material over-issuing, resulting in enhanced compliance with procedures and regulatory standards• Collaborated with stakeholders by leading time and motion studies for lean management, redesigned workflow and floor plans, reduced handoff delays, and enhanced communication, significantly increasing delivery speed in line with VSM goals• Redesigned kitting tags for seamless integration with Scan to Bay (SAP) and Dock Control systems, significantly enhancing work order visibility, streamlining logistics, and boosting customer satisfaction.• Utilized ETQ and Intelex Document Control to maintain the Training Matrix within Quality Management System, ensuring regulatory compliance and minimizing downtime of operations• Meticulously crafted and revised SOPs and SWIs, ensuring alignment with current processes while clearly defining responsibilities, enhancing quality system compliance and efficiency within the department• Utilized Power BI and Excel to analyze and correct labor hour discrepancies, resulting in improved productivity reporting for ROF

• Took ownership and successfully led and managed a team of 11 associates in material mobilization and relocation for ASML, resulting in a seamless transition to a 138K SF site with minimal downtime and disruption to production

• Directed 35 associates charged with scaling BKO and supply chain management for Lam Research, a supplier of wafer fabrication equipment to the semiconductor industry, in a 388K SF warehouse, achieving recognition as a top 10 site nationwide for employee engagement.• Key member of a startup that created daily production schedule and reconciled forecasts by leveraging Power BI, SAP ERP, and Microsoft Excel tools (e.g., pivot tables, formulas) to ensure operations met daily plan of 80+ lines• Identified opportunities to deliver exceptional client outcomes by recognizing gaps in processes and undertook steps to improve production, resulting in lead conversion for all shareholders• Reconciled account data of daily movements using in-transit reports to clear DIFF buckets while ensuring compliance and accuracy of import/export activities

• Supervised 80 associates tasked with order fulfillment and supply chain management in a high-volume, 372K SF warehouse for Lam Research• Initiated process improvement and enhanced team output to deliver exceptional customer satisfaction through thoughtful and practical improvement of SWIs• Key contributor to Fetch Autonomous Mobile Robot project that evaluated ROI and CBA for automating manual movement in the facility• Project specialist charged with achieving 100% bin accuracy of SKUs in Kardex VLMs and cycled in the highest turn SKUs, which resulted in increased customer satisfaction

• Member of Process Support Group (PSG) charged with monitoring the sortation system and interacting with conveyor mechanics and operations employees to ensure core business processes remained online to meet Daily Operational Plan (DOP) and expected delivery dates• Identified adverse patterns and trends in image-based code readers through analytical efforts and worked to reduce production loss to achieve greater operational efficiency• Delivered environmental, regulatory, safety and health compliance training per DOT, OSHA and UPS’s Comprehensive Health and Safety Program (CHSP) requirements whereby fostering safety-first mindset in the workplace

• Charged with training and managing Designated Responders tasked with properly containing and removing hazmat spills per government regulations for DMP• Reduced Left in Building (LIB) metrics by identifying ways to correct processes/workflow and retrained employees in best methods resulting in the hub ranking second west of the Mississippi for overall performance• Promoted wellness and strived to maintain a safe work environment for union employees and management professionals by conducting observations and DOKs to mitigate risks and recognize employees for safe work behaviors• Meaningfully elevated customer satisfaction by accurately, reasonably, and efficiently processing DMNs across all sorts within 24 hours of notification

• Independently devised, created, and implemented steps in responding to the Novel Coronavirus to address Left in Building Frequency and On-Time Network metrics by training staff in UPS Overgoods and correct processes/workflow

• Spearheaded development of new advertising materials to increase impressions and lift engagements of clinical study facing recruitment challenges• Maintained awareness of attention to details by readying clinical supplies and processing, conducting and finalizing biospecimens for shipment with no discrepancies or citations reported• Self-initiated and designed key regulatory documents for study start-up while kept with GDP and ALCOA-C Principles and supported maintenance and creation of regulatory binders• Collaborated with PI on updating study documentation and provided ad hoc reporting as part of annual review of approved study by IRB

• Worked with co-founder on evaluating a novel solution to drug shortages that complicate patient care and lead to adverse clinical consequences. Hoped to resolve failure through network that would have facilitated efficient distribution of lifesaving therapies by addressing imbalance in supply and demand.

• 11 therapeutic areas in 15 Clinical Clerkships• Performed informed consents and ensured compliance with ICH Good Clinical Practice• Demonstrated high levels of multi-tasking by managing time constraints and unpredictable schedules through methodology that re-prioritized tasks• Approached challenges as opportunities to improve skills by seeking mentors

• Exhibited highly developed verbal communication skills in creating accurate, informative, and in-depth writing on clinical research subject matter for poster presentation• Displayed strong regulatory compliance with FDA and state clinical research regulations and policies, including ICH GCP, Health Information Portability & Accountability Act (HIPAA), Protection of Human Subjects (Common Rule), CLIA, and best practices.• Demonstrated sound understanding of computer applications and utilized diverse skill set to harvest big and small data from databases to manage and report study results to internal stakeholders

• Accepted all requests to complete training requirements and ensured compliance with cGMP by maintaining training records• Championed quality improvement measures to prevent workplace accidents by fostering safe working practices and filing reports of problems through designated channels• Encouraged team members to implement 5S workplace organizational and housekeeping methodology so work could be performed efficiently, effectively and safely

• Undertook data management activities by auditing study findings in LIMS to maintain data integrity and audit readiness while not being personally tasked by management• Proactively worked with the department to strengthen SOPs by improving quality assurance procedures to prevent future issues with monitoring program for daily operations• Ensured uninterrupted flow of operating conditions to internal stakeholders by achieving 100% of deadlines through effective communication and prioritizing ad hoc monitoring activities• Self-initiated inventory work orders for purpose of maintaining equipment in satisfactory operating conditions and minimizing downtime• Delivered meaningful results to study center partners by ensuring quality and data comparability of all biological samples through sound management as part of the qualification review of the manufacturing facility

• Identified important quantitative and qualitative methods of assessing fitness in sampling units by performing an investigation of research opportunities to study host immunity