University Northridge Data Entry

Samantha P. Arvizu

Cell: (***) *** – **** Email: ********@*****.***

EDUCATION

Bachelor’s Degree in Biology - Spring 2013

California State University Northridge, Northridge, CA

Relevant Coursework: General Biology I and II, General Chemistry,

Organic Chemistry I and II, Embryology, Human Physiology,

Human Anatomy, Genetics, Comparative Anatomy, Cell Biology

Master's Degree in Emergency Management - April 2016

Purdue University (formerly Kaplan University), Davenport, IA

Relevant Coursework: Introduction to Graduate Studies in Public Safety, Academic and Professional Communications in Public Safety, Research Methodology, Crisis and Emergency Management Fundamentals, Risk, Vulnerability and Capability Assess Methods, Planning and Operations in Crisis and Emergency Management

Graduate Certificate in Business Management 360 – April 2021

Cornell University, Ithaca, NY

HONORS and AWARDS

MBRS Compensated Research Program 2011- 2013

Golden Key International Honor Society - 2015

National Society of Leadership and Success 2007- 2014

Alpha Beta Kappa Honor Society - 2015

PUBLICATIONS and PRESENTATIONS

Publications Co-Authored in:

“Kinetic Analysis of Reagents Affecting Cell Clumping” -Presented at FASEB National Conference in Boston, MA - Spring 2013

“A Possible Cell Surface Mechanism for Magnesium Sulfate’s Anti-thrombocytic Activity” - Presented at FASEB National Conference in San Diego, CA - Spring 2014

RESEARCH EXPERIENCE

California State University of Northridge, CA 2011 - 2013

Minority Biomedical Research Support-Research Initiative for Scientific Enhancement (MBRS - RISE) Paid Program

Undergraduate Researcher - Mentor: Dr. Steven Oppenheimer- Cancer Research

Worked with yeast cells as a model for cancer cells and mixed one reagent into yeast cell model; Applied different reagents, either salts or sugars to discover which reagent(s) best help separate the yeast cells; Collected the necessary data, graphed the percentages, and maintained laboratory daily; Calculated the percentages of the single cells throughout every trial; Assisted graduate student w/ thesis by updating photos of sea urchin embryos and labeling sea urchin embryos.

Prepared and enhanced photographs for graduate student’s presentation.

Dissection and labeled sea urchin embryos: Dissection of the archenteron was performed under a microscope through the utilize of pin needles. Sea urchin embryos were placed on microscope slides, needle had to pinch the archenteron on correct spot, if not the archenteron could not be removed properly.

EMPLOYMENT HISTORY

CW- Quality Specialist II – ThermoFisher Scientific (Mindlance Staffing) Oct 2020 - present

Provide tracking/trending logs/reports; addressed and tracked quality issues that arose from NCR or from Internal/External quality system audits; inventory; worked with complaints (Complaint Information, Event Reporting, Product Recovery, and Investigations); responsible for launching and writing stability test plans and reports for LinkSeq HLA & HPA, LABScreen, LABType, TTT, FlowPRA, AllType FASTplex NGS, and MicroSSP product families

Software Utilization: SAP, HLA Fusion, MasterControl, and SureTyper

CW-Sr. Associate – Amgen (Astrix Staffing) Nov. 2020 to Oct. 2021

Inspection of: vials of media and/or liquid product, syringe vials with liquid product, lyophilized vials with product, and cartridge vials with liquid product

Inspection consists of: rejecting vials with contaminations, embedded foreign matter, stains, impurities of unwanted particulates, check marks, cracks, lehr stickers, external & internal airline strips throughout the vial, damaged plungers/pistons, barrels, caps, rippled foil, etc.

Computer Vision Annotation Tool (CVAT): utilization and inspection of photographs of vials and/or syringes with defects. Product Inspection for: WFI/CCI; NPSP; Media; ABP 938; AMG 171; AMG 609; AMG 199; AMG 794; AMG 757; AMG 701; AMG 160; AMG 659; AMG 654: AMG 157; AMG 498; AMG 427; AMG 404; AMG 334; AMG 124; AMG 592: AMG 501; AMG 145

Packed out/Packaging for: syringe vials for Aranesp; NPSP.

Daily Software Utilization of: Smartsheets (for tracking Inspection training, schedule, SQDIP, certification reminders, etc.) & PASX/MES (for EBR documentation).

CW-Sr. Quality Analyst I– Shire/Takeda (Sunrise staffing agency) Sept 2020 – Nov 2020

Responsible for performing the day-to-day quality operations for QA Product Release within the Quality organization. Identify and assess quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices.

Responsible for reviewing pertinent documents, records and reports such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.

Identify areas of non-conformance and inform management via the drafting of Deviations as needed to be disposed (unilaterally accepted or rejected) by others. Deviations at this level are minor and involve no patient risk; Performs initial investigative actions on Deviations, applying well-established techniques and procedures

Administer and maintain relevant databases, preparing and issuing reports as defined by the area; Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.;Revise or review standard procedures. Revise SOPs in support of Division Procedure Compliance or continuous improvement efforts as needed.

Maintain and update departmental business indicators. Prepare metrics for the Management Review of Quality Systems.

Audit/review documents as needed for completeness, cGMP's, company procedures and verification of data. Correct any deficiencies found.

CW-Sr. Quality Assurance Associate – Amgen (Ronin staffing agency) Feb. 2019 – July 2020

Upstream/ Cell Culture Processes: Scale A & B, Wave A & B, N and N-1 (500L), N-2

Downstream/Purification Processes: Affinity Chromatography (ProA), Viral Inactivation (VI), Cation Exchange Chromatography (CEX), Mixed Mode Chromatography (MMC), Viral Filtration (VF), Ultrafiltration/Diafiltration (UF/DF), Ultrafiltration/ Diafiltration Install (UF/DF Install), Final Filtration (FF) and locking the MIC.

Document Review: Review and Cross-check signatures and initials, current dates, expiration dates, times morning and afternoon (AM/PM), equipment numbers for MP’s, Samples, Sample Plans, Events, EUR’s, Media Batch Records, and Buffer Batch Records. BRR Document Review done for AMG 256, AMG 199, AMG 910, & AMG 171. EBR Document Review done for AMG 570, AMG 701, AMG 334, & ABP 501.

Citrix Reciever/MES/WERUM/PASX software utilization: general day to day transactions processed were to review take out logs in Shop Floor Orders (SFOs), review exceptions in Batch Record Reviews (BRRs), utilize Intray, review take out logs, cross-check CQA’s.

Maximo software utilization: look-up and cross check asset numbers for equipment (scales, pumps, flowmeters, timers, pressure transmitters and welders); asset numbers must/had to be at least a level 1 or 2, active, and activation date had to be initiated before equipment was utilized.

Trackwise: Ran Queries

PI software: Review and Cross-check Trends/ Tags, searching and/ or adding PI tags

Harvest Trends included: Agitator Output, Agitator Start/Stop, Transfer Pump Output, Transfer Pump Start/ Stop, Vessel Pressure, Agitator Speed, Vessel Temperature, Vessel Weight, Vessel Dissolved Oxygen

Chromatograph Trends included:

(AKTA) Current Methods, Batch ID, Current Block, Block Volume, Column Outlet Flow, Column Outlet Conductivity, Column Outlet pH, Column Outlet UV, Feed Pump Outlet Pressure, Column Outlet Temperature

(Chrom skid) Post Colum UV 280 nm, Post Column UV 300nm, Pre-Column Flow Totalize in Column Volume, Pre-Column Conductivity, Pre-Column pH, Post Column Conductivity, Post Column pH, Pre-Column Flow Control Loop Process Variable, Pre-Column Pressure, PI, Batch Phases, Pre- Column Temperature, Post Column Temperature

Viral Filtration Skid Trends included: Pressure Control PV, Feed Flow Totalizer, Differential Pressure, Filter Inlet Pressure, Filter Outlet Pressure, Batch Operation, Batch Phase,

UF/DF Skid Trends included: Feed Flow Process Rates, Permeate Flow Rate Process Value, Feed Flow Total, Permeate Flow Total, Feed Pressure Process Value, Retentate Pressure Process Value, Permeate Pressure Process Value, Retentate Tank Temperature, Agitator Speed Process Value, Retentate Vessel Level, TMP Control Process Value, Inlet Pump Flow Input

Performed Changeovers in Upstream/Cell Culture Area: Confirmed the following; no prior product was still on-site, equipment was sterile, pipette filter was changed if used, proper documentation, sterile hood.

Commission and Qualification: Reviewed Protocols and Commissioning and Qualification Summary Reports (CQSR); Crosschecked System numbers and titles in Maximo, TR numbers and titles in Trackwise, SOP numbers, versions, titles in CDOCs, RPT numbers, versions, and titles in CDOCs, PLAN numbers, versions, and titles in CDOCs, Work Order (WO) numbers and titles in Maximo; Crosschecked Exceptions numbers and information.

Ensure adherence to GMP and GDP regulations for each area of operations and associated processes.

Deliver quality and compliance Oversight Assessments and GEMBA walks to maintain an inspection ready facility in the Early Phase Pre-Pivotal Drug Production and Commercial Production Areas.

Daily utilization of Smartsheet Software.

Thermo Fisher April 2014 – February 2019

Laboratory Technician - Central Operations Department

Document Review for Temperature Monitoring Logs: Review and Cross-check signatures and initials, current dates, expiration dates, times morning and afternoon (AM/PM), equipment numbers, probe numbers, correct freezer and/ or deli temperature range is checked, a valid temperature was written and corresponds to the freezer and/or temperature range, verify (UDR) unplanned deviation numbers and nonconformance report numbers (NCR)

SAP Software utilization: general transactions processed are MB1A, MB1B, MMBE, MB25, ME51N, ME52N, COOIS

Inventory and Kanban monitoring and ordering: general items in kanban are pipette tips, 1000ml- 250ml vacuum filter bottles, 1000ml storage bottles, Wypall teri wipes, latex and nitrile gloves (XLarge, Large, Medium, Small, XSmall), beard covers, hairnets, shoe covers, strip caps, acrodisc syringe filters, 20uL tip racks, Eppendorf combi tips, syringes, tubes, Versidry surface protectors, Non-sterile solution basins, 96 well tube plates, envirocide, bleach, kim wipes, labels

Media preparation for Cell Culture: general reagents and products used for media preparation are Bovine Calf Serum, Penicillin Streptomycin

(Pen Strep), and RPMI 1640 Medium; preparation performed under hood; hood cleaned with envirocide and mycoplasma; gloves, product, and instruments cleaned with 70% alcohol

Gel Agarose preparation for Gel Electrophoresis: Small and Large gel preparations

Luminex (LABScan3D, LABScan 100, Luminex 200, FLEXMAP 3D) Calibrations: flush and clean probes with syringe, utilization of sonicators, utilization of calibration kit and performance verification kit, perform weekly maintenances, perform six-week maintenances

Antigen Purification Buffer Preparations: Cell Lysis; 1X PGP Elution; 1X PGP Binding; Buffer #3.1; Buffer #3; Buffer #5 w/ Doc; Buffer # 5 w/o Doc; Antigen Storage; Buffer #1; 1X PBS; Cell Wash; Buffer #2,4; Elution Buffer (pH 11.5); Elution Buffer (pH 11.0); Neutralization Buffer (pH 7.8); 20% Ethanol; 500x EACA; 200X PMSF; 0.1M DOC; EDTA; 10% NP40

Lab type Buffer Preparations: 0.2M MES; 0.2 MES 1M MaCl (pH 4.5); 0.1M MES, 0.5M NaCl (pH 4.5); 0.2M MES; 1M NaCl; 0.1M MES; 0.5M NaCl; 0.02% Tween; 0.04% Tween; 1X PBS 1mM EDTA; 0.1% SDS

20% Bleach preparation, Staging/Pulling Primer Oligonucleotides, Managing Biohazards, pH meter calibration, Cold Storage Temperature verifications and/or monitoring, REES System software utilization, Smart-Vue Freezer and Deli monitoring and utilization, 5S, PPI and GEMBA walks, Standard Operating Procedure Draft Writing and Editing, Procedure Redlining and Collaboration, File (UDR) unplanned deviations and (NCR) nonconformance report, Autoclaved Water Preparation, Autoclaving glass, Monitoring Incubators, Replacement and Monitoring CO2 Tanks, Worked in cleanroom environments, Practiced aseptic techniques, Interviewed new employees, Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Personal Protective Equipment (PPE) regulations

Laboratory Technician - Production Department

Blocking Buffer preparation, PBS Buffer preparation, Antigen Head Washing Buffer preparation, Wash Buffer preparation, All Set Gold Buffer preparation, 10% Bleach preparation, Aliquoting, Wipe Test Aliquoting, Utilization of Video Ink Jet, VIAFLO 96 Micro SSP Dotting Terasaki Trays, Micro SSP/ Lambda Cell Trays (LCT) / Lambda Antigen Trays (LAT) / SeCore Packaging, Checking dry and wet SSP trays, SAP data entry, Autoclaving, Managing Biohazards, pH meter calibration, Cold Storage Temperature verifications and/or monitoring, REES System software utilization, Procedure Redlining and Collaboration, Knowledge of Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Personal Protective Equipment (PPE) regulations

State Compensation Insurance Fund- Seasonal Clerk 2013-2014

Sorting, Copying, Scanning, Organizing extremely crucial and private files/documents: involving social security numbers, passport copies and identification, addresses, driver’s license numbers/ID, last names, middle names, first names, birth dates, birth certificates, insurance claims & documentation

Spreadsheets: data entry

SKILLS AND CAPABILITIES

Teamwork and ability to work independently

Problem-Solving/Reasoning & Analytical/Research Skills

Hard-Working and Perseverance

Dependable/Reliable/Responsible

Strong computer, scientific, and organizational skills

Excellent oral and written communication skills

Ability to learn new techniques by engaging in the proficiency of others

Ability to work effectively in a fast-paced team environment

Multi-tasking abilities Willingness to Learn

Experience in: Maximo, LIMS, Citrix Receiver MES/PASX, Trackwise, PI, SAP

Self-Motivated/Ability to Work with Little or No Supervision.

Typing speed: 40 WPM

Proficient in Microsoft Word, Excel, and PowerPoint,

Outlook, Smartsheet, OneNote

Languages: Spanish - Professional Proficiency Level

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