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Supply Chain Management, Change Control Management, CAPA management, M

Location:
Mooresburg, TN
Salary:
140000
Posted:
January 10, 2025

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Resume:

Alexandra Sundock

*** ****** ******, **********, ********* 37811

864-***-**** **********@*****.***

PROFILE

I am a highly adaptable, hardworking professional with a proven track record of driving cost reductions, maximizing efficiencies, and creating a more amicable team environment through integrity, collaboration, and communication. With leadership and mentoring, I have been able to exceed job performances resulting in excellence in audit performance reviews, improved customer service and better stakeholder relationships, responses, and overall process improvements & performance. With over 20 years in logistics, operations and supply chain; serving international and domestically, becoming internal administrators on new systems within several positions allowing for maximum efficiency and cost savings. 20+ years of extensive auditing, investigations in a variety of capacities using different processes and tools within ISO guidelines.

EXPERIENCE

Pfizer Remote

Project Manager Serialization 2022-Present

oSupport markets with financial process for systems sterilization migrations

oDrive serialization projection communications and business adoption

oSupport training rollout, document updates and change management

oPartner with cross functional teams to ensure processes are performed in accordance with DSCSA regulations

oOversee the systems switch to SAP, ATTP using ICH middleware

oManage multiple work streams within serialization providing business input, coordinating and consulting actions, impacting and escalating actionable impacts for 7 direct reports

Civica Rx Lehi, UT

Supply Chain Serialization Analyst 2020-2023

oExecute validation test scripts and onboarding protocols.

oActivate and oversee multiple partner connections

oOversee new vendor and serialization setups

oParticipate in UAT testing for systems implementation and maintenance

oPartner with cross functional teams to ensure GxP processes are performed in accordance with regulations

oPoint of contact for troubleshooting activities related to the system

oFacilitate business and project team for system implementation

oCreate and provide ongoing support and maintenance of deployed solutions including SOPs and Work Instructions.

oCreate and maintain all Master Data activities with new or ongoing suppliers.

oAssist with 3PL warehouse delivery scheduling, warehousing, order fulfillment, and shipment of products to our hospital systems

oClose collaboration with customers, suppliers, contract manufacturers and 3PL

oVerification of all products in/outbound to end user (hospital system)

oCreate and maintain all serialization electronic change control documents

oGood understanding in the systems, applications, tools and processes that enable improvements in domestic and global Supply Chains including, Supply Planning; Global Export and Trade Compliance; Shipping & Logistics; Warehouse & Inventory Management, Serial Tracking and Secure Supply Chain

oInvestigate, create, report, and drive progress on non-conformances and remediation, including root cause analysis and implementation of both corrective and preventive measures, and track progress of investigations through to completion

oCreate processes and procedures for new divisions of Civica, Inc (CivicaScript and Civica Fill Finish Facility).

oPlans and processing with all partners of the DSCSA 2023 serialization standards to improve efficiencies

Acro Services (Contracted to BPX Energy – short-term project) Houston, TX

Contracts Management (PSCM) 2019 – 2020

oEffectively manage various contract categories simultaneously

oEngage in strategical thinking for process improvements and cost saving measures

oCreates, develops, maintains positive working relationships with suppliers, stakeholders, and team members

oManagement of strategic initiatives, key supplier relationships, total cost effectiveness, and risk assessments

oCreates, completes, and liaises on new contracts with vendors, legal, contract operations, and stakeholders.

oEnsures compliance with said Master Service Agreements are accurate with down-hole and midstream operations

oDocument and analyze transition and transactions from previous BP entities to BPX for cost effectiveness concerning capital assets

All-Tech Systems (Contracted to BMW Manufacturing) Greer, SC

Supply Chain Planning Specialist 2015 - 2017

oDevelop medium to long term supply chain processes and methods influencing supplier decisions, logistics costs, by/including adding new and/or optimizing existing methods of supply, incl. emergency strategies using corporate standard concepts

oDirecting all day-to-day production activities to ensure daily, weekly, and monthly production quotas are met.

oLeading cross-functional project teams, representing all Logistics departments/strategies in Plant core teams, break-out teams and other special tasks associated with projects

oUsing innovation, created a packaging concept that saved over $12M for BMW over the lifecycle of 1 model.

oKeep track of quality, quantity, stock levels, delivery times, transport costs and efficiency

oPlan, coordinate, and execute supply chain routes from supplier to plant (NAFTA, Europe, China)

oOversaw every phase of supply chain, from purchase order to delivery to invoicing, targeting 100% end-user satisfaction

oStreamlined office operations using automation, oversaw client communications, managed record tracking and data communication activities

oAchieved 100% reduction in delay time through on-time warehouse operations and deliveries.

oDirected inter-modal domestic and overseas import and export operations to ensure proper maintenance of schedules in alignment with deadlines

oSaved $12M+ by researching and implementing an innovative approach to packaging cost-saving initiatives and creating fresh new approaches to long-standing problems

oDeveloped team communications and information for cross-functional project meetings

Fluor (Project Completed) Bagram, Afghanistan

Country Audit Compliance Officer, Sr. Theater-wide Property 2010 – 2013

oDeveloped, implemented and managed daily, semiannual, and annual risk assessment and the organization action plan to address risks theater-wide, created SOP’s& SOW’s

oEstablishment of Compliance Manual and formal audit program and processes where required

oProtect the interests of the company by leading company-wide efforts to develop, document, and implement procedures to ensure compliance and regulations of US Government and company standards

oTasked with creation of a new internal audit position, create all new procedures and processes, ensure personnel theater wide were using best practices, and created sustainability for said position which led to increase cost savings and winning the re-compete awards with the US Government valued at over $500M

oConducted Investigations theater-wide concerning assets that were either lost, damaged, destroyed, or stolen; Created corrective action for such; Liaised with top tier Government officials for clearance of such actions.

oManaged quality assurance program including on site evaluations, internal audits and customer surveys

oNegotiated agreements between employees to clarify misunderstood directions and resolve conflicts affecting performance

DynCorp International LLC (Project Completed) Baghdad, Iraq

Sr. Theater Logistics Supervisor, Logistics Coordinator 2007 – 2010

oAudited over 20 locations in theater of which we received excellent from the US Government, allowing us to win the next multi-million-dollar contracts

oStandardized Logistics, Supply chain, and Operational Management theater wide; trained all personnel in country personally on techniques and software management

oManaged over 13 camps logistically and operationally. Creating sustainable locations by mentoring, hands on training, communication, thorough investigations techniques, and using best practices. Resulting in excellent status during client audits

oReviewed established business practices and improved processes to increase efficiencies and reduce expense without compromising customer service levels.

oBuilt continuous improvement culture that attracted and retained high-performing employees while reducing costs

oCreate, implement, and maintain safe business practices and daily safety topics/training

KBR (Project Completed) Baghdad, Iraq

Sr. Materials Specialist/Vehicle Armoring Lead, Materials 2004 – 2006

oCreated and maintained vehicle maintenance’s armoring program in country, creating significant life saving measures and driving massive cost reductions of over $15M

oSupported entire country of US Military, Civilian Contractors, and Coalition forces in armoring advances and innovation.

oMaintain metrics and analyze data to assess performance and implement improvements

oCreated single source contracts improving quality, cost savings, and delivery times

oOrganized warehouses using efficient Lean organizational practices

oAdjusted procedures as needed to maximize department effectiveness

oAssessed areas of service concern and developed improvement plans

oContacted location managers and department supervisors to assess requirements

oManaged quality assurance program including on site evaluations, internal audits and customer surveys

ITT Systems (Contract Completed) Doha, Qatar

Sr. Production Control/Logistician (database administrator) 2002 – 2004

oPerform inventory management for timely delivery and to reduce long lead times, reducing costs for expedited deliveries

oIncrease part and component availability by improving planning process and inventory accuracy

oDaily usage of technical manuals/drawings

oOversee the production scheduling process to achieve profit objectives with continuous improvement of production and on time delivery schedules to customers

oCreate goals & milestones for a diverse team that enabled them to thrive and exceed production and productivity, exceeding the overall readiness of 90% to nearly 100%

oAchieved Excellent from the US Government on overall readiness reports, enabling contract extension and later re-award of over $680M

EDUCATION

Colorado Technical University Colorado Springs, CO

Bachelor of Business Administration 2014-2019 (open)

* Deans List

Six Sigma Corporation Macomb, MI

Green Belt, Lean Six Sigma Certification 2015

GS1 Standards for DSCSA Suppliers Online

GS1 Standards for Product Data Excellence Online Certificate Course 2022

CORE STRENGTHS & SKILLS

Supply Chain Management, Change Control Management, CAPA management, Materials Management, Safety Management & protocol implementation, Operations Management, Cold Supply Chain, Inventory Management, Lean Processes & Practices, FARS/DFARS, DEACOM, ITAR (International traffic and Arms Regulation), (Rfxcel, SmartData, Transportation & Planning Management, Maintenance & Supply Management, Project Management, Distribution Planning & Execution, Production Scheduling, Vendor Management, Highly adaptable, Customer Service, International & Domestic Supply Chain & Logistics Management, HAZMAT training and coordination, Warehouse setup/Coordination, Inventory Management, Multi-plant Creation, Contract Management, Sourcing & Procurement, Contract Negotiations, Risk Assessments, Demand Planning, Planning & Forecasting, Truck Load Planning, SWOT analysis, Regulatory Compliance & Auditing, Training & Development, KPI Management, Conflict Resolution, Team Building, Cross-Functional Communications Management, Import/Export, Deadline Driven, Adaptability, Cost Reduction/Avoidance, MRO, Maximo, ATTP, ICH, Veeva, MS Office, Peachtree, ERP Systems, Oracle, SalesPoint, SharePoint, QuickBooks, SAP, Ariba, and more…



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