SHANNON NICHOLAS

Quality Systems Specialist & Manager

PERSONAL INFO

570-***-****

advtst@r.postjobfree.com

https://www.linkedin.com/in/shannon-nicholas-aaaaba104/

*** ******* **. ************, PA 18445

PROFESSIONAL ACCOMPLISHMENTS

Trained employees on GxP's and contamination by creating SOP's for the Laboratory and for the Quality process.

At an International Food Manufacturing Company, was a leader in investigating and eliminating their Listeria Genius contamination.

Audited and overhauled the Quality Department of an International Food Manufacturing Company new to the U.S., and an Established Biotechnology Company.

Created SAP Catalogue for Vendor’s CoA, and Check List of acceptable parameters for vendor perishable goods shipments. The was used in improving Vendor Relations.

Trained 500+ employees on topics such as aseptic technique, GMP’s, and cross contamination in English and Spanish.

Created a pamphlet that both employees and customers could utilize to understand the processes of Monoclonal and Polyclonal Antibody manufacturing, and the different options available for production and final state.

As the only Quality CTD Trainer of a large pharmaceutical company, I helped re-design trainings which were instrumental in significantly decreasing human-error deviations.

PROFESSIONAL EXPERIENCE

Quality Specialist Coordinator

Thermo-Fisher Scientific Allentown, PA June 2022 – present

This position is broken down into two primary areas:

1.The first part is to be the person that goes between the QA Doc Control Department and Production.

a.Receive all records including batch records, change controls, protocol’s, etc.

b.Log all incoming records to be reviewed, completed, and uploaded into GPM, Microsoft Access’ Error Tracker, and Excel Spreadsheets for the analysis of metrics and for Quality Specialists.

c.Check records for completion.

i.If incomplete, contact necessary staff to obtain needed forms.

d.Upgrade & Automate Batch Record Spreadsheet.

2.The second part of my position is the redesign of the QA Doc Control office and how records are processed.

a.Re-evaluate the filing process

b.Develop JA’s for the QA Doc Control Department

c.Re-design how logging and metrics are completed.

d.Make the process more automated for a quicker, more streamlined process.

e.Assign “light-duty” employees with tasks

I have also begun training for batch record pre & post review as a Quality Specialist.

EDUCATION

Degree Granting Programs

Bachelor of Science

Microbiology/Biotechnology

Minor Chemistry

Delaware Valley University of Science and Agriculture

Doylestown, PA

August 2004- May 2008

Online Non-Degree Courses

Quality Management Systems: Management and Operational Excellence Training

Udemy.com

Currently Enrolled

Certified Six SigmaBlack Belt (+ Excel Application)

Udemy.com

Currently Enrolled

Problem Solving

PROFESSIONAL EXPERIENCE CONTINUED

CTDO Quality & Training Specialist

Bristol-Myers Squibb Summit, NJ May 2021 – Jan. 2022

My role in this position was to support CTDO Quality Systems by:

Training incoming staff on the basic processes involved in Quality Systems.

Deviations, CAPA, Change Management

oRoot Cause Analysis Tools

5 Why’s, Fishbone

oALCOA+

Training staff on Quality Systems computer programs used to initiate quality process.

oeQRMS, Infinity

oAided Senior Managers in the Quality

Systems Group with daily tasks.

oCAPA metrics and reports; APQR

oReviewing Deviations and CAPA’s

oRunning CAPA approval and review meetings.

Assisted people with training in ComplianceWire

Experience with right first time, SQUIPP, and VEEVA computer system.

Assist with Quality role of Deviations and CAPA’s

Bilingual Manufacturing Trainer

Language Directions LLC. Roseland, NJ Oct. 2019 – Jan. 2020

While teaching at the various companies, I would need to put together a training plan, create presentations, worksheets, and research each topic in the fullest capacity.

In this position, I used my experiences and education to train Administration Staff in:

Basic Spanish in Manufacturing

Supervisor Skills.

Auditing Skills

These courses were designed so the Administration of any Manufacturing Facility have the ability to:

o Better communicate with production staff

Dangers in the facility

o Have the skills to lead.

What is necessary to efficiently conduct a Production Audit for contamination and safety.

Giving them the skills to head an external audit from customers, USDA, FDA, etc.

Lab Manager & Head of Quality/ Lead Immunochemistry Researcher

PRF&L Canadensis, PA March 2019- June 2019

Focused on the investigation of the compounding of various immunoglobulins (IgG) by administering a biological mixture to vertebrates. Simultaneously, I was responsible for researching a new product through the Immunohistochemistry of vertebrates. to be sold to Pharma Companies in the investigation of new vaccines or drug therapies.

Head of CAPA

oCustomer Complaints.

oAll Reports.

oInvestigations

oChange control.

Head Of Micro & Quality

oEnvironmental Monitoring with Aseptic technique.

oTrained employees in Aseptic Technique

oLead quality control and micro testing throughout the facility.

Led all IgG production, investigations, testing, purification, and reports.

Quality

Key Skills

SHANNON NICHOLAS

PROJECT MANAGER & QUALITY MANAGER

Leadership

Training Skills

Languages:

Spanish:

Read:

Write:

Speak:

Additional Skills

Access

Anatomy

AP Smart

Aseptic Technique

Auditing

Autoclaving

Basic Research

Basic Web Development

Binder Creation

Biochemistry

Biology,

Budget

CAPA

Chemical Chromatography

Chemistry

Clean Room

Client Relationship

Customer Service

Data Science

Development

Dialysis

Distillation

Document Management

Electrophoresis

ELISA

Excel

External Audit

FDA Auditing & Regs

GLP/GMP/GXP

GPM

Internal Audit

Internet Research

ISO 9001

Lean Six Black Belt

LIMS

Management: Lab & Quality

Manual Lab Testing

PROFESSIONAL EXPERIENCE CONTINUED

Lab Manager & Head of Quality/ Lead Immunochemistry Researcher Continued

PRF&L Canadensis, PA March 2019- June 2019

Purifications using column chromatography.

oUltralink

oSulfalink.

Antigen conjugation also with column chromatography to elicit an immune response.

owith KLH or BSA.

oMaleimide

oSmall molecule (BSA)

Protein purification,

oIgA, IgG, IgI, IgY.

Mass Spectroscopy

Membrane and centrifugal dialysis,

Lyophilization,

Aseptic sera separation,

Chicken embryo neural crest stem cell collection.

Equipment Calibration

Took on compounding injections to be administered to all species of vertebrates for in vivo production of polyclonal or monoclonal antibodies to the given protein or peptide.

oUsed various adjuvants and buffers to create mixture.

Used a wide variety of other scientific techniques for investigations and research especially:

oELISA, various types of Column Chromatography, and Mass Spec.

Created pamphlet to help clients and staff alike understand what we offered and the procedure for each.

Helped staff with all technical questions and calculations.

Additional Skills Continued

Mass Spec

Metrics

Microscopy

Microsoft Office

PowerPoint

Payroll

PCR

Presentations

Project Management

QC/QA

Reporting

Research

SAP

SOP Author & Revision

Spanish

Supply Estimation

Sy

Teaching

Technical Writing

Troubleshooting

Trainer

Translation

USDA Experience

Veeva

Vitec

Vidas

Western Blot

PROFESSIONAL EXPERIENCE CONTINUED

Temp. Quality Supervisor/ Raw Materials Specialist

Bakkavor Foods USA Jessup, PA April 2017 – July 2017

While at Bakkavor Foods, I was placed in the Quality Supervisor position with minimal training, as the Quality Director and Supervisor left on the same day 2 weeks after being hired. I accomplished much more than I had originally anticipated while at this company including:

Creating an SAP program with a binder

Instrumental in leading the team in abolishing the Listeria Genus contamination that had plagued their food production facility,

Trained the entire company of 500+ employees, presented in English and Spanish) in

o GMP's and Preventing Contamination

Created a COA program

oEstablished qualifications for incoming raw materials.

Led Environmental Monitoring and Aseptic technique in clean room environment.

Bioburden testing.

Review all paperwork for Quality Department.

oInput all results into a LIMS type system.

oCreate reports for Out of Spec. batches

oProvide monthly product and budget reports to head office.

Monitoring Microbial testing for batch.

Assessed final micro results for product release in Syspro

Created, reviewed, and revised SOP'S.

Was given responsibility of CAPA Program from Director of Quality.

oReceived customer complaint and spoke to customer.

oInvestigated complaint

oCreated Customer Complaint and Investigation reports

oCorrective actions to address the deviation

oLed department heads in initiating change controls

Communicated test results and deviations from company policy to various department heads.

Created CoC to send with any samples to the lab.

Responsible for sending samples to third party lab and continue communication regarding samples and results.

Responsible for all aspects of Raw Material testing including:

ocreation of specs and requirements for materials,

ologging and evaluating all COA's,

odetermining acceptability of material by creating specific parameters for the pass/fail of shipment.

. Created Raw Material Binder which included

oEach raw material

oVendor Sending raw material

oCOA and specifications for pass/fail

PROFESSIONAL EXPERIENCE CONTINUED

Managed 11-14 QC/QA techs on three shifts.

Presented all Quality Lessons for building in English and Spanish.

Worked with finance department:

oFor any matters regarding Quality and R&D Departments.

oITR's all paperwork,

o Balanced budget in Syspro and AP Smart

Communicated regularly with the USDA and FDA on label creation, product release.

oVersed in SQF, HAACP

Quality Assurance Microbiologist

Friesland Campina Domo Delhi, NY October 2009- February 2010

Clean room, aseptic technique, and gowning.

Determined the presence of

o S.Typhimurium, S.Aureus, E.coli., and Enterobacteriaceae

By using a variety of assays including streaking plates for oxidase/catalase test using Vitek.

Reported all results using LIMS.

Extensive product filtering for all 60+ products

Reporting in SAP for all product results.

CGLP/GMP.

Q.C. Microbiologist

Sanofi Pasteur Swiftwater, PA 2009

To identify bacterial or fungal sample: streaking plates and a variety of assays including

osub-culturing, gram staining, catalase/oxidase, Microdase, and indole tests.

Also responsible for all bacterial identifications on VITEK Analyzer machine.

Responsible for continuous environmental monitoring in a GMP/FDA regulated environment.

Performed water, endotoxin, and microbial endotoxin tests.

Sterility testing in vacuum sealed cube.

Extra sterility, gowning and aseptic technique classes.

Compliance and deviation.

PROFESSIONAL EXPERIENCE CONTINUED

Heavy Metal Forensic Chemist

NMS Labs Willow Grove, PA 2008

Daily preparation of biological/chemical samples in a clean room environment.

Performed tests for heavy metals in biological samples using

o ICP-MS,

oICP-AES,

oGraphite Furnas,

oand AA (Alan)

Troubleshooting and Cleaning of all Instrumentation

Reported results as needed in LIMS

Prepared Report for Legal Use

Food Microbiologist; summer position

QC Laboratories South Hampton, PA June 2006 – August 2006

Prep of food samples for micro testing.

Test food samples for pathogens such as:

o E. coli, Listeria genus, Listeria mono, Salmonella, Shigella, and Staphylococcus genus microbes.

oTest for confirmation of species for E. coli sub-species and Listeria species.

Used Vidas 1 and other instrumentation to test samples.

VOLUNTEER EXPERIENCE

Project Engineer

OfficeRX Commack, NY June 2019 – August 2019

I was contacted by an entrepreneur through a job board for a position of planning, setting up, and beginning a lab that was intended to be for Nutraceuticals. My tasks were as follows:

1.Begin planning what testing would be needed to satisfy microbiological testing for nutraceuticals.

a.Plan what equipment would be necessary for the planned testing, and any other state and/or federal requirements.

b.Research the state and federal laws and requirements for a Biotech Lab, as well as all requirements from the FDA, Dept. of Health, and any other rules and regulations required to run the lab.

2.Based on the space given by the entrepreneur and the amount of testing needed, begin researching the best equipment for the job, with no budget given.

3.After the necessary research and planning was completed, I gave a formal report and presentation to said Entrepreneur.

4.Find the researched equipment and calculate the price.

a.After discussing the prices with the Entrepreneur, the purchasing of the equipment would begin.

VOLUNTEER EXPERIENCE CONTINUED

Office Manager

VOLUNTEER EXPERIENCE

Project Engineer

OfficeRX Commack, NY June 2019 – August 2019

I was contacted by an entrepreneur through a job board for a position of planning, setting up, and beginning what was intended to be a Nutraceuticals Lab. My tasks were as follows:

1.Begin planning what testing would be needed to satisfy microbiological testing for nutraceuticals.

a.Plan what equipment would be necessary for the planned testing, and any other state and/or federal requirements.

b.Research the state and federal laws and requirements for a Biotech Lab, as well as all requirements from the FDA, Dept. of Health, and any other rules and regulations required to run the lab.

2.Based on the space given by the entrepreneur and the amount of testing needed, begin researching the best equipment for the job, with no budget given.

3.After the necessary research and planning was completed, I gave a formal report and presentation to said Entrepreneur.

4.Find the researched equipment and calculate the price.

a.After discussing the prices with the Entrepreneur, the purchasing of the equipment would begin.

Office Manager

Douglas Marshall LLC. Mount Pocono, PA Sept. 2016-Jan.2017; Sept 2018- March 2019

Complete all tasks generally completed by management

Conducting internet research for any paperwork necessary for the company

Communicating with external vendors, customers, including translating for non-English speaking clients.

Gained proficiency with Microsoft Office, Excel, and PowerPoint, QuickBooks

Wrote insurance write ups for all jobs done by team.

LLC prep research and paperwork to establish company as LLC.

Tax paperwork

Licensing applications and registrations

Accounts Receivable and accounts payable

Payroll

Authoring Insurance Submissions

International Import/Export Analyst

Walton International New York City, NY Sept. 2017 – Dec. 2017

This position was presented as a competition. An unknown number of candidates would compete through testing. We would get a chapter of material to learn in one week. At the end of the week, a test would be given. At the end of the testing, the person with the highest grade would be given a position within the company, with a generous salary, benefits, vacation time, etc. The material learned is as follows:

Basic Management Training and Verification of Cargo

oLicenses necessary for cargo

IE. Live cargo, Pharmaceutical products, etc.

Customer Relation Training

oReceiving Payment; Late Payment

oLate Delivery or Non-Delivery

oLost Cargo

Rules & Regulations for U.S. international exports

oCustoms-Trade Partnership Against Terrorism (C-TPAT)

oAuthority and Terminal Operator (MPTO)

oWarsaw Convention

oMany more

VOLUNTEER EXPERIENCE CONTINUED

International Import/Export Analyst Cont’d

Work with U.S. Federal Agencies

oFDA

oUSDA

oUS Fish and Wildlife Services

oU.S. Bureau of Alcohol, Tobacco, Firearms and Explosives

oU.S. Department of Defense

oAnd others

Cargo Receipt

oInternational Ports

Rules and Regulations of International Ports

oUnloading and shipping cargo

Contact this candidate