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Media Value Stream Lead Resume Example

Resume Score: 80%

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MEDIA VALUE STREAM LEAD
Summary

Seeking a fulfilling position as a Business Analyst/QA Analyst and support of all IT needs that offers growth opportunities and allows me to utilize my technical and leadership skills.

Skills
  • SDLC processes
  • Agile
  • Requirements gathering
  • User Acceptance Testing
  • Manual Testing
  • Business process improvement
  • UML Diagrams
  • Test Cases
  • MS Office (Word, PowerPoint, Outlook, Excel, Access, Visio)
  • Fluent in Python, JavaScript, C++, HTML, PHP, SQL
  • Linux
  • Inventory management
  • Manufacturing Systems (SAP, MES, LIMS)
  • Systems implementation
  • Familiar with 21CFR211, 21CFR820, ISO 13485, ISO14971
  • Excellent Verbal/Written Communication skills
  • Technical support
Experience
Media Value Stream LeadJan 2020 to Current
Novartis Pharmaceuticals - Morris Plains, NJ
  • Facilitate the Work Cell & Tier 1 meeting
  • Coordinate the team for the daily activities and personal adjustments as necessary.
  • Worked closely with the Manager to ensure the performance of the department and the team members.
  • Supervise the training of new employees to ensure they have the vital technical skills, Aseptic Technique and knowledge for ISO 8 and CRF.
  • Work with MES Team for improving and making the system user friendly.
  • Provide Training and support to end users on new MES system during production.
  • Participated in assigned qualification/ validation activities.
  • Troubleshoot MES related issues during production.
  • Provide mentorship to less knowledgeable Media trained associates.
  • Assist the Manager with communication on job related information during daily meetings.
  • Enforcement of outstanding cGMP and aseptic behaviors
  • As Subject Matter Expert, support any deviation investigations that involve your work environment
  • Ensure control of inventory between ISO8 Dispensary with SAP ISO 8 & Media Activities.
  • Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.
Cell Processing AssociateJun 2018 to Jan 2020
Novartis Pharmaceuticals - Morris Plains, NJ
  • Gowned aseptically into grade C and D to work in a clean room environment.
  • Executed dry runs of media process to test electronic batch record.
  • Oversee media module and provide support to all media activities.
  • Train new associates in operating and verifying bioreactor days and media process.
  • Aseptic processing in ISO 5 biosafety cabinets.
  • Universal precautions for handling human derived materials in BSL-2 containment areas.
  • Provide support to peers on operations as MES Super User.
  • Used production related IT systems such as SAP, MES and LIMS on daily basis.
  • Performed in process operations such as: bioreactor sampling, static sampling and in process environmental monitoring.
  • Worked with automated cell processing equipment such as the wave bioreactor.
  • Documented all steps in the assigned Batch record in line with GMP requirements.
  • Cell expansion using incubators and single use bioreactors.
  • Assisted on deviation investigations and inspections.
  • Maintained an “audit ready” module
Antisera Formulation SpecialistApr 2017 to Jun 2018
Ortho Clinical Diagnostics - Raritan, NJ
  • Handled formulation and processing of Antibody Reagents and Diluents in accordance with written procedures and specifications.
  • SAP Power User: Performed (ERP) inventory transactions, adjust quantities work orders, cycle count, MUV analysis and scrap authorizations. Ensure availability of materials/components for efficient operation. Accurate data entry skills in ERP system.
  • Worked with Human blood in process of formulation.
  • Performed in process review of batch records/witnesses formulation of products. Document work done and perform all support functions on compliance with departmental, company, and government procedures and regulations.
  • Performed in process testing as required by processes and procedures utilizing equipment/instrumentation such as: pH meter, specific conductance, viscometer, spectrophotometer osmometer, calibrated pipettes, centrifuges, incubator and water bath.
  • Wear the appropriate PPE when working in lab environment and other hazardous working environments.
  • Participated in investigations regarding new products and process improvements, as required. Responsible for using equipments for the assembly and processing tasks to produce products according to established specifications.
Manufacturing OperatorFeb 2015 to Nov 2015
Ortho Clinical Diagnostis - Raritan, NJ

•Troubleshooting of routine manufacturing equipment and processes

•Maintains and performs basic repair on labeling machines and equipment •Inspecting various product put-ups to ensure product is free of defects

•Perform in-process review of batch records and documents work done •Demonstrate complete understanding for all processes and performs all assigned manufacturing tasks

•Responsible for labeling of all products

•Good knowledge of math and metric system

•Check product on assembly line to confirm that they are properly assembled •Complies records and reports on quality inspection results

Education and Training
Bachelor of Science, Management Information SystemsDec 2019New Jersey Institute of Technology - Newark, NJ

GPA: 3.7

  • Magna cum laude graduate
  • Dean's List Honor
Associate of Science, ChemistryJun 2014Raritan Valley Community College - Somerville, NJ
Projects

Project Name: MES Implementation (Electronic Batch Record) Novartis Pharmaceuticals; March 2019- Present

Role: MES Subject Matter Expert

  • Design, implement, and test MES System based on the Business process flow.
  • Responsible for the design, implementation, and verification of electronic Master Batch Records (MBRs) for Cell Processing Operations
  • Develop protocols, test cases and executed IQ/OQ/PQ for Balances and Printers, including calibration procedures.
  • Provide MES support for production.
  • Implement and maintain LIMS interactions and calculations, AQWA for deviation generation during the process, and interface with SAP system to issue materials to MBRs that are acceptable & released.
  • Configure/update MES to support change requests.
  • Communicate with MES Global Novartis Team to ensure that local MES is aligned with the Global format and structure.
  • Accurately control the release of proprietary documentation.
  • Coordinate the review and revisions of procedures, R&D documentation and FDA regulations for inclusion in Production instructions and quality control manuals.

Project Name: GTFS (Mobile App) NJ Transit; September 2019- December2019

Role: Business Analyst

  • Participated in all phases of Software Development Lifecycle (Planning, Analysis, Design, Development, and Implementation) to deploy a software product.
  • Developed a Mobile friendly App for NJ Transit which allows the users to check bus schedule and track real time bus location.
  • Engage project sponsor to gather project requirements/business rules and ensure alignment with development team.
  • Translate project requirements into tangible deliverables such as functional specifications, use cases, users stories, and UML diagrams
  • Evaluate risks related to project requirements, deliverables, and personnel.
  • Perform testing to unsure all functionalities meet the requirements.
  • Facilitate weekly sprint meetings with team to track progress.
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Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

Companies Worked For:

  • Novartis Pharmaceuticals
  • Ortho Clinical Diagnostics
  • Ortho Clinical Diagnostis

School Attended

  • New Jersey Institute of Technology
  • Raritan Valley Community College

Job Titles Held:

  • Media Value Stream Lead
  • Cell Processing Associate
  • Antisera Formulation Specialist
  • Manufacturing Operator

Degrees

  • Bachelor of Science , Management Information Systems Dec 2019
    Associate of Science , Chemistry Jun 2014

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