Customer Service Social Media

Shaunette Ambush

**** ***** ****** **. *** *** Phone: 240-***-****

Frederick, MD 21701 Email: *****@***.***

Qualification Summary

Sample Processing: Aliquot, Receive and Process Covid-19 Bulk Drug Substances (Stability, Retain, Endotoxin Bioburden and Turbidity…)

Coordinate Inbound/Outbound shipments for Covid-19 Samples and other Drug Sample Products

Process Stability Samples for Clinical Trials (Phase I, II, & III Covid-19 Vaccine) and other Specimens (tissue, blood, plasma and serum and other bodily fluids)

Obtain Certificate of Analysis (COA’s) for Chemical Inventory

Operate King Fisher and Hamilton Machines for Molecular Biology

Read and understand a variety of Drug Sample Plans Protocols for Analytical and Microbiology testing methods

Maintain knowledge of Corporate and Program Policies and Procedures.

Familiarity and experience with cGxPs and Maryland COMAR (Code of Maryland Regulations)

Writing, reviewing, and following SOPs, OSHA, FDA & ISO & Tobacco Compliances

Benchtop skills in a Maryland state laboratory and in a biopharma environment

IATA Certified (shipping Biological Specimens)

Certification to administer Narcan (Noloxone HCL)

Customer Service and Account Receivables experience

Licensed Income Tax Preparer

Accomplishments

Phase I, II, III- FDA Approved & Marketed Vaccines- Johnson & Johnson (Emergent BioSolutions); Astra Zeneca (Catalent Pharmaceutical)

Processed Covid-19 Bulk Drug Substances for Adenovirus Vaccine (Reference Standard and Critical Reagents) other tests for pH, appearance, osmolarity, clarity etc.

Represented Emergent BioSolutions for their Covid-19 Pandemic: 2 National News Segments and photographs for their Marketing Campaign

Processed Clinical Trial Samples according to their Specifications, Protocols and

GMP/GDP Documentations

Created a Company Wide Inventory Database for Emergent BioSolutions

Implementing new features in LIMS System (LIMS Change Request)

Biotechnology Student Support System Group at Frederick Community College, acknowledging variety of ways in Networking, Community Events, Social Media, Communicating with other Health and Scientific Colleagues.100% Tobacco Compliance (July and August 2018)

Developed a new Hazard Analysis Critical Control Point (HACCP) Plan database for the Frederick County Health Department

Inspected food safety for Frederick County Public Schools, restaurants and stores pursuant to Maryland COMAR regulations

Performed environmental monitoring and laboratory testing for Frederick County Health Department

Increased Frederick County Health Department revenue by collecting on past-due facility revenue licenses

Education

B.S., Biotechnology UMGC at Shady Grove

A.A.S., Bioprocessing Technology Frederick Community College, 2013

A.A., Business Administration Frederick Community College, 2003

Skills and Qualifications

Benchtop skills (Process Biological Samples/Specimens, Aliquoting, streak plating, serological pipetting, micro-pipetting, and serial dilutions)

Familiarity and use of Biological Safety Cabinets (BSC: Class 2 & 3) and PPE’s, Pipettes

Experience in following SOPs in a GLP and GMP environment, Documentation, Investigation and Research skills

Microscopy, streak platting and straining

Buffer and media preparation

Experience in laboratory machinery (autoclave, centrifuge, PCR machines etc.)

Professional Experience

Eurofins PSS

Sample Management Feb 2022-present

Ability to perform multiple tasks simultaneously, manage time effectively, and ability to follow written procedures and instruction

Material Receipt and Inventory activities

Aseptic aliquot of samples from a source bulk

Submission of samples to testing laboratories

Use of Good Documentation and Practices to generate and review documentation during storage and submission.

Population and maintenance, using data integrity principles, of databases that support inventory and sample submission activities

Receive samples, acquisition, and enter sample management system (LIMS)

Transport and track samples within and across labs

Ship samples using internal management system

Cian Diagnostics Nov 2021- Jan 2022

Molecular Laboratory Technician (Intern)

Process Covid-19 Samples for Schools, Institutions and Walk-in Patients

Operated King Fisher and Hamilton Machines

Processed and Retested Covid-19 abnormal results.

Stocked supplies and other duties as assigned

Astra Zeneca

Sample Management (Contract) May 2021-Jan 2022

Oncolytic Translational Medicine (R&D)

Receive samples, acquisition, and enter sample management system

Transport and track samples within and across labs

Ship samples using internal management system

RNA/DNA purification and characterization from multiple sources (frozen tissue, FFPE tissues, blood, plasma, BMA, sputum, etc.) utilizing various methodologies

Sample processing for next generation sequencing data generation

Develop and execute of qRT-PCR assays on multiple platforms preferred but not required

Maintain detailed laboratory notes on experiments, generate reports summarizing experimental results and communicate them to project teams.

Catalent Pharmaceuticals

Sample Coordinator Specialist (Contract) Jan 2021-April 2021

Receive and Process Biological Samples (Covid-19)

Sampling of raw materials according to established specifications

Sample coordination and receipt from other departments for internal and external testing

Scheduling of QC testing and activities

Sending out of test samples to Contract Testing Laboratories (CTL)

Follows up with CTLs on testing and turnaround times to ensure testing deadlines are met

Trending of all CTL test results

Works closely with Manufacturing, Analytical Development and Process Development for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination

Effectively communicates updates and results from CTLs

Flexibility in following unique campaign requirements that may include off-hour and weekend work

Other professional duties as assigned

Emergent BioSolutions Bayview

(Lead)

QC Laboratory Support Technician (Covid-19) (Contract) Mar 2020- Oct 2020

Process Biological Samples: Covid-19 Adenovirus Viruses (SARS Cov-2rs) Bulk Drug Substances and other Drug Substances Products

Sample Management, Assisting with Sample Receipt and Shipment, Sample aliquoting

Sample log-in by creating unique Quality Control Identification numbers

Perform Specimen disposal activities, electronic & document controlled archival

Preparing solutions for analytical and microbial testing

Contact vendors for Certificate of Analysis

Inventory control of Reagents and Supplies (per temperature controlled)

Creating LIMS ID#’s for Inventory: for variety of Analytical Testing Methods

HPLC, Assays, PCR, DNA/RNA markers, SDS Page etc.

Routine equipment maintenance (monthly and routine cleaning of BSC, incubators, water baths, eye & shower wash, etc)

Ordering departmental and office supplies

Log-in and monitor logbooks, tracking temperatures

Monitor freezers, refrigerator and room temperatures as assigned by Manager

Operate Steris Glassware Machine

Carry out other duties as assigned professionally

Precision for Medicine Dec 2018- Jan 2020

Biorepository Technician I

Commercial- Frozen

Precision Bio Services

Monitoring of freezers:

Respond to freezer alarms in accordance with standard operating procedures

Monitor freezers, refrigerator and room temperatures as assigned by Manager

Receive biological samples:

Unpack specimens and record all pertinent information in Incoming Shipment Batch and incoming folder

Create a folder to house all associated paperwork

Store at appropriate temperature following guidelines set by procedures

Distribute confirmation of shipment receipt form if required by project

Receive supplies into inventory:

Verify shipment contents against packing list

Quarantine Raw Materials for release by QA department

Inventory of Frozen Biological Samples:

Check information on sample vial against information provided by the study site

Scan samples into data management system, BSI

Correct paperwork where necessary and inform supervisor/manager of any discrepancies by generating a discrepancy report

Assist in the inventory of returned specimens

Aliquot frozen specimens utilizing aseptic technique

Retrieve Frozen Samples from Inventory and Ship:

Process Clinical Trial Samples (tissue, blood, plasma and serum and other bodily fluids)

Pull samples according to requisition, SOP, and instructions

Perform quality control verification of outgoing samples

Update Outgoing Batch Record

Contact receiving labs prior to shipment to confirm shipping address and ensure contact will be available to receive specimens

Ship samples (dangerous and non-dangerous goods) by Commercial or local courier

Complete all paperwork (link-up forms, aliquot forms, return forms or BSI data collection sheets and any other forms which may be necessary)

Miscellaneous:

Label vials and shipping boxes

Perform dry shipper QC

Keep current on IATA Shipping Regulations and maintain certification and standards

Carry out other duties as assigned professionally

Wawa Inc. July 2017- Aug 2018

Lead Customer Service Associate

Sheetz Store March 2015- July 2017

Shift Supervisor

Colbert-Ball Tax Services Jan 2016- present

Income Tax Preparer/Consultant (seasonal)

Internship: Frederick County Health Department Jan 2013 - May 2013

Environmental Health Specialist Trainee- Food Safety Inspector

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Pharmaceutical Technician – Capricorn Pharma July 2011-January 2012

Quality Control, Fill and Finish

Upstreaming/Down Streaming

Prepped Adult and Children Cold Medicines for Retail (shipping) - Zicam Cold Medicine.

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