Quality Assurance Control

Madeline E. LeSuer

Location: Piscataway, NJ / Phone: 732-***-**** / Email: **************@*****.***

Professional Experience

Gilead, Morris Plains, NJ April 2023 – June 2023 (remote – contract)

Quality Assurance Specialist

Reviewed clinical manufacturing, packaging, and labeling drug product batch records, in-process quality control data, assess completeness of change controls, deviations, and test results for timely disposition of drug products intended for human clinical use and issue material status notifications

Facilitated and participated in deviations, corrective action and preventive action (CAPA) activities, and complaints for assigned projects

Served as QA lead on project teams, in complex quality investigations/deviations/clinical compliant investigations and Corrective Action/Preventive Action (CAPA)

Performed batch review, approval and release as assigned

Maintained electronic records in TrackWise, Oracle Enterprise Business Suite (EBS), Gilead Electronic Batch Review Systems, Veeva Vault, etc., and paper archives as needed

Interacted with key stakeholders such as Formulation and Development, Clinical Packaging & Labeling, Clinical Supplies Management, and Regulatory Affairs to ensure that clinical drug products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations

Trained junior staff and may perform other supervisor responsibilities as requested

Assisted management with gap assessments, streamline and improved existing workflow and quality procedures.

Bristol Myers-Squibb, Warren, NJ July 2021 – January 2023

Specialist, Quality Assurance

Reviewed Cell Therapy patient batch records for Manufacturing and Quality Control and released in Oracle

Completed raw material packet and batch record review and released in Oracle

Initiated deviations, tracked NCRs/CAPAs in eQRMS, OBIEE, and Infinity to assess and investigate deviations/non-conformances

Utilized Veeva Vault, OBIEE, Infinity, and GPS Salesforce to verify patient/batch/lot information

Printed and issued batch records, forms, and other required documents to internal departments such as Manufacturing, Quality Control and Quality Operations

Maintained batch logbooks for company’s patient cancer products and associated Quality Assurance cabinets, ensuring proper filing of batch information

Completed binder/issuance requests of batch/lot documents for other departments; filing as needed in patient document file room

Emailed/Messaged via Microsoft Outlook and Teams to other internal departments (QA Operations, Quality Control, Supply Chain, and Manufacturing) regarding patient and batch information

Communicated with senior leadership in internal departments regarding vital patient and batch information

Abbvie (formerly Allergan), Branchburg, NJ April 2019 – July 2021

Quality Control Analyst/Product Review Coordinator

Reviewed batch records of human tissue – verifying histology, MD review, serology, autoclave, and inspection

Initiated/tracked NCRs/CAPAs in TrackWise to track, regulate, and investigate deviations/non-conformances

Worked with senior leadership to update SAP system and improvements and team training

Utilized metrics/formulas in SharePoint and Excel daily to establish steady supply chain flow of product release (approx. 50-75 batches daily)

Communicated daily with supporting departments – QC Final Inspection, Production, Manufacturing, Histology, Tissue Receipt regarding release of materials, ETAs, reworks of product, and batch completion status

Assisted department manager/director on administrative tasks daily, and with weekly/monthly reports

Tracked and updated QC Release’s metrics in Excel, Power BI Tracker, PowerPoint and SharePoint daily

Provide tissue samples, disposition paperwork and batch information to R & D department for research and education

Assisted team with inspecting human and porcine tissue finished goods to ensure high quality standards are met

Completed manual pull and release of product daily, verifying accuracy of batches and piece count

Processed quarantine holds/dispositions for materials related to deviations/non-conformances/CAPAs

Performed time studies with OpEx team to improve process flows throughout entire Quality Control department

Worked closely with Supply Chain team to ensure product availability for each month (US, Europe, & Asia)

Created Certificates of Conformance to provide to Kuehne & Nagel contacts for shipment of product domestically and overseas

Trained peers in department on product reworks, shipping processes, and electronic transfer of product in SAP

Reorganized QC Product Release file room, including batch records, histology reports, Micros, and RMAs

Reviewed Dose Audits and change controls with Tissue Release department monthly, giving feedback and reports to manager

Worked with logistics department weekly to schedule trucks for product shipment to local distributors and

to R&D department as needed

Processed E-Beam sterilization and dosimetry reports regularly, uploading them to team’s shared drive

Maintained and used SOPs/LOPs/checklists in Veeva Vault for batch records and product updates

Updated workflows and process flows in Visio as needed for Quality Control Release and Final Inspection

Hosted daily tier meeting with team to review daily goals, accomplishments

Reviewed employee timesheets in Workday

Airgas (AirLiquide Company), South Plainfield, NJ Aug 2017 – Apr 2019

Supply Chain Coordinator

Processed mass order of medical, industrial, pharmaceutical, and food grade gases via SAP

Routed purchase orders for the truck shuttle schedule daily, working closely with the distribution managers for the entire NJ/NY/PA region

Called/emailed account managers, customer service specialists with updates on orders and stock requests

Used SAP daily to regulate incoming/outgoing stock, supplying the plants/branches based on demand

Processed employee travel and reimbursement in Concur Travel

Worked closely with major production plants nationwide to process and ship gas orders daily

Scheduled, processed, and arranged shipping for tube trailers via common carriers overseas to Korea

Covered other territories for co-workers as needed

Assisted accounts receivable with problem invoices, research and gather supporting documentation and submit corrections as required

Provided customer support to internal and external customers in relation to Specialty Gases

Analyzed and maintained the supply and flow of gas cylinders for customers via SAP and Excel spreadsheets

Traveled to various plants, distribution centers, and branches for meetings and territory procedure updates

Identified the urgency of orders and reported to necessary departments to ensure on-time delivery

Reviewed purchase requisitions for vendor ordered product and stock transport orders for specialty gas products, converting the requisitions to purchase orders in SAP

Participated in weekly meetings via phone, and WebEx for Supply and demand for the Metro-NY territory

Maintained a high level of customer service by assisting sales force via telephone, email, fax, or in person.

Caesarstone, Perth Amboy, NJ Jun 2015 - Apr 2016

Supply Chain/Logistics Fulfillment Specialist

Assisted customers with purchases of materials and promotional items/samples

Entered and generated sales orders into the Oracle system, creating pick sheets for local distribution centers

Created and processed customer orders, purchase orders, shipping orders, and requisitions to determine

items to be moved, gathered, or distributed/shipped for fulfillment of orders

Contacted customers regarding order status, driver ETA, availability of backorder material, and various

account-related tasks

Completed various daily tasks for warehouse manager and supervisor, including opening and closing office

Provided excellent customer service via phone, email, fax and in person to vendors, guests, and employees

Reviewed open work orders via Microsoft Excel, updating status and sends them to management for review

Worked daily with accounts receivable department regarding customer accounts and payment processing

Processed credit card payments for customer accounts via online credit system

Provided support to sales team, promoting Caesarstone product and up selling to customers, and

to fellow office and warehouse employees as needed

Worked with logistics department to determine freight costs, ETA and availability of material

Scheduled drivers’ daily truck routes to NJ/NY/PA/CT, dispatching to customers and vendors

Worked with logistics department to determine freight costs, ETA and availability of material

Processed RMAs and warranty orders for damaged/defective inventory

Assisted in counting/labeling of physical inventory as needed

Completed order forms and other necessary documentation to order supplies for office and warehouse

Facilitated weekly multi-department manager/staff conference calls for NY/NJ and CA headquarters

Education & Skills

Bachelor’s Degree, Supply Chain Management, Rutgers University, New Brunswick, NJ – May 2024

Associates Degree, LA Psychology, Middlesex County College, Edison, NJ – May 2012

Associates Degree, Fine Arts Theatre, Middlesex County College, Edison, NJ – May 2012

Proficient in: Microsoft Office Suite and Teams/SAP/SharePoint/Oracle/TrackWise/Veeva Vault/HQMS/Infinity

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