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Title Quality Assurance & Inventory Control Lead, as well as IC Analys
Target Location US-PA-Allentown
Email Available with paid plan
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Candidate's Name
Quality Assurance & Inventory Control Lead, as well as the Inventory Analyst - FedEx Supply Chain - Consumer HealthcareKunkletown, PA Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLEI am very passionate about my role in management for QA/QC and in Supply Chain management as a whole, as it has taken me down many avenues with many more avenues to explore. I am continuously learning and eagerly look for opportunities to gain knowledge from all resources available in order to be the best that I can be in my field, for the business, my team and especially the customers. I firmly believe that one&#Street Address ;s knowledge and the manner in which one interacts with others (ethics, morals, values, etc.) can and should be improved upon and made stronger throughout their lifetime. We are who we are because of the many components that have shaped us since birth. When we come to an age that we know who we want to be and how we want to portray ourselves to others, we can then modify those components working towards a goal to be the best version of ourselves that we can possibly be. A facility with a team where many of them understand how to and have been consciously working towards being the best version of themselves that they can be, will absolutely be a facility that will stand out among their competitors. A team working towards goals such as this will be quality driven with a strict QMS in place, which is key. With a strict, well planned out and well written QMS at the forefront, everything else will fall into place with minimal quideance, as it should because an effective QMS will demand it. A facility with a team that builds their foundation with these key components will have guaranteed success. With guaranteed success the team of that facility will have a very satisfied and delighted customer, who is going to give them a signed contract term after term as long as that team continues to support and improve the foundation and the QMS that was put in place.Authorized to work in the US for any employerWork ExperienceQuality Assurance & IC Lead, Inventory AnalystFedEx Supply Chain - Consumer Healthcare - Tobyhanna, PA November 2007 to April 2019In my role I was responsible for several areas of Quality Assurance and Inventory Control, as well as Inventory Reconciliation between RP and SAP. I held these three titles simultaneously for this 1.5 million square ft. facility, FedEx Supply Chain with Johnson & Johnson, Consumer Healthcare as the customer. The responsibilities at my previous places of employment encompassed all areas of Quality Compliance, Quality Assurance, and Inventory Control. Quality as a whole is an exciting profession with many, many divisions. I am an expert in each of the positions I held and take pride in the knowledge that I have. There is much more that I continue to learn and always will by utilizing whatever sources necessary to do so. This area is rapidly changing all the time and I plan to not only keep up with the knowledge of these changes, but I will be an expert in everything I take on. Within the three roles I held I was responsible for troubleshooting and assisting in disposition with all Quality and/or Inventory Issues that arise in every area of the operation, including; Inbound, Outbound, Transportation, Customer Service, Customer OS&D's, Customer Issues, Product Holds, Teammate Issues, Training, Safety, Security, Maintenance, Record Retention, and any additional Quality Assurance/ Compliance issues that arise. Responsible for assisting with FDA Audits, VAWD Accreditation, GMP Audits, DEA Audits, Internal Audits, ASQ/ANSI/ISO 9001:2015 certified, and able to assist with all audit requests. Experience in assisting in the back room of audits. I have the ability to run the back room of a large audit. I assist in overseeing the day to day operations of the QA Auditors. Initiate, investigate, verify, and trend NC's and CAPA's. Write, review, update SOP's and WI's, according to the current QMS standards. Write and oversee deviations and protocols or choose team, train team and oversee protocol written or requested by the customer ensuring that all instructions are being carried out correctly and documented thoroughly. Responsible for organizing and managing deviations and protocols written by our QA department or our customer's (Johnson & Johnson) QA department. When performing a deviation, this process includes communicating the Quality issues, product affected, lot codes, quantities, documenting which SOP/WI document, also including the number(s) of the sections in the SOP or WI which we would be deviating from and send to Customer QA Manager and Director of Operations for any additional information requested and approval signatures if any changes were necessary and corrected. If disposition was agreed upon I would facilitate all necessary Teammates, Training, and Equipment necessary to carry out this Deviation. When completed product is held until further disposition is received. When a protocol is drafted and all necessary signatures from FedEx Supply Chain and Johnson & Johnson the Protocol is performed as the directions are written by either FedEx Supply Chain or Johnson & Johnson. I would have the same responsibilities along with my signature verifying that the process was done as it was written and all quantities are correct. The product is then held for further disposition as a later date. Responsible for investigating any reported PSE unusual event reported by customers or internally and report my findings to the FedEx QA Management Team, the Operations Manager, Inventory Manager, the General Manager and the Support Manager. The J & J QA Manager,, Operations Manager, Business Lead and a few additional individuals that change depending on the issue. Our inbound team document all inbound issues in a database, which I then upload, with disposition, to the J & J Sharepoint, which is monitored for tracking and trending of a large amount of information, which assists us in working together with the Customer and most of all the vendors to make the inbound process efficient, quality driven, safe, productive, accurate and most of all profitable.. I have worked with the J & J team on several large projects saving several thousand dollars in assisting in resolving these issues. Took on a key roll in introducing a new WMS system to the entire staff at the DC and assisting with any issues teammates may have had during ramp-up. Also, played large role in the roll out of voice picking and picking two pallets at a time, which were two new procedures beginning at the same time. Each of these new roll outs saved the DC and Johnson & Johnson a large amount of revenue in several areas. I also assisted in the introduction and setting up of AGV's (Autonomous Guided Vehicle) in our facility. We were the first DC in the country to have AGV's from Baylo located in France. I consider myself fortunate to have been a part of it.All of my training in Quality and Supply Chain took place in a facility with a very strict, well wrtten, well planned QMS in place and I consider myself lucky to have been given the opportunity to do so. It gave me the knowledge, the discipline and the confidence to do my job efficiently and with professionalism and expertise. Every facility should be GMP and audit ready at all times with each and every associate in the facility understanding exactly what that means from their first day of employment. Knowledge is power. Six Sigma and LEAN are practiced in all I do. Participation in Kaizen projects and sigma six has been part of my interactions with all departments in our facility. Partnering with Johnson & Johnson and McNeil Pharmaceuticals, I have managed and led several global Temperature monitoring studies, including rail, sea and air and just recently a global temperature mapping study which I led and managed at the Tobyhanna, Johnson & Johnson site I led and participated in QDM projects, which are very important the growth of our industry and business by saving money, time and resources. I was one of handful of people in our facility who held SAP access. I used SAP primarily in my role as the Inventory Analyst, which I held simultaneously along with the role of Inventory Lead and the role of Quality Lead. I mostly used SAP to investigate, document and reconcile the inventory variances between the DC's WMS system (RP) and Johnson & Johnson's (customer) WMS system (SAP) then uploaded that information on spreadsheets and reports in SAP., As Invnetory Lead I responsible for overseeing the Inventory Control team and Damages and Reclamations. I requested all inventory activities to assist in resolving issues for the customer or for issues found in my investigations or monitoring the operational activities, such as: lot codes, item numbers, lpns, adjustments, misplaced, pilferage, configurations, mold, spills, etc... Processed Quarantine Holds and Releases, Temperature Alarms, and Import PSE (Pseudoephedrine) shipments and investigations. If it is found that it was truly missing and it was due to a break down in our process, then I would report to the DEA. Policies were very strict with Handling List 1 Chemicals. I assisted in the filing of the 486 paperwork, amendments, and return declarations to the DEA due to the fact that the DC held a PSE code that was imported from Canada, which i also oversaw. i managed the damaging and destruction of all PSE product including security to and from incinerator. Excellent at multitasking and working with the customer and various Operational Teams to meet our production SLA's with Quality as a priority, while keeping inventory in sync and accurately receiving and shipping quality product to customers. I was fortunate to have been asked to manage and lead several special projects partnering with J & J QA manager and McNeil QA manager. Including Temperature studies, by land, rail, sea, and air. The magnitude of data retrieved from these studies will prove to be a huge financial savings for everyone in the industry. Vendors will learn what set points to set their TMD's at or if they even need them at all. And those that aren't using them and do need them will also save millions of dollars in product that would otherwise have to be destroyed if the temperatures didn't stay in the parameters specified for that product.Manager/Green Goods BuyerFullerton Home & Garden Showplace - Ledgewood, NJFebruary 1998 to January 2002Responsible for buying all plant material for retail sales in the garden center and yard, as well as all plant material for jobs that the landscape architects on site designed and sold to high dollar clientele. Also responsible for overseeing 25 employees in the yard, unloading trucks, making deliveries and maintenance. Also, responsible for the setup of the yard and pricing of plant material from the simplest of shrubs to 20" - 5"caliper trees. This 5-acre Gardens Center covered all facets of lawn and garden installation and maintenance from start to finish. It was my responsibility to make sure that my team kept it looking like a showplace. We sold wholesale, retail and also did home landscapes for elite customers upon request. My main job was to travel to trade shows and work with salesman all over the country to get the best quality product for the best pricing and dating. My responsibilities included the setting up of the delivery of the plant material and reordering when needed. I also held special events such as Customer Appreciation Days and Weber Grill Days. My knowledge in plant material and disease and insect let me work one on one with the customers to troubleshoot and issues they may have with their plants or landscaping material. I also trained and developed my staff to understand how to provide proper customer service. EducationHigh school diploma in BusinessStroud High School - Stroudsburg, PASeptember 1984 to June 1988Skills Inventory (10+ years) Inventory Control (10+ years) Kaizen (10+ years) logistics (10+ years) operations (10+ years) Microsoft 365, Microsoft Office, Red Prairie WMS, SAP.,visio, outlook, General Business, QA Assurance Management, QA Compliance Management, Inventory Control Management, Supply Chain Management, Supervisor, Subject Matter Expert in many Supply Chain areas, licensed on all Operational equipment QA Quality Assurance Quality Control Haccp Root Cause Analysis GMP FDA Internal Audits Quality Management ISO 9001 Lean Quality Audits ERP Systems Research & Development Quality Systems Lean Manufacturing Warehouse Management Six Sigma QA/QC Quality Inspection Oracle 5S Auditing Purchasing Warehouse Management System Product Development Agile Forecasting Computer NetworkingLinkshttps://LINKEDIN LINK AVAILABLE Certifications and LicensesISO9001-2015 Internal Auditor CertificationPresenttrained to do internal audits and all that pertain to findings Additional InformationSKILLSQuality Assurance, Quality Systems, ISO9001-2015 Certified Internal Auditor, SOP/WI Writing, Revising and Editing, NC Processing, CAPA Processing including; identifying problem, assessing impact, Quality and Regulatory Management Notification, Investigation Process, Complete investigation, Determine Root Cause and Corrective Actions, Plan Effectiveness, Verify effectiveness to make sure that problem has been resolved and monitor to ensure it is not recurring, documenting and implementing Deviations by performing and documenting, enhanced, thorough, objective description. Next, document correction description plans and what process, including the number of that process in the necessary SOP's and/or WI's that identify the process you are requesting to deviate from. This portion of the deviation also explains the reason that you are requesting to deviate from the process. Quality approval is received, and you train the necessary Teammates and Management or all Teammates that are in the job function this deviation will be implemented in. Risk Assessment, Risk Management, Investigations and Verifications, Trending, Inventory Management, Inventory Control, Inventory Reconciliation, Supply Chain/Logistics, Warehouse Operations, Shipping, Receiving, Inventory Management, Inventory Analysis, Inventory Reconciliation, Inventory Analyst, Logistics, Management, Customer Service, Process Improvement, Cross Functional Team Leadership, Business Process Improvement, Investigation, Materials Management, Supply Chain Optimization, Warehouse Management Operations, Team Leadership Building, Team Building, Lean Operations, Six Sigma, Kaizen, QAT and QDM, Garden Center Management, Microsoft Office 365, Microsoft Excel, Microsoft PowerPoint, SAP and RP WMS System Knowledge, Team Development, Tracking of Controlled Substance, Investigation of Unusual Report of Controlled Substance by Customers, Perfect Safety RecordLINKShttps://LINKEDIN LINK AVAILABLE

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