Quality Specialist & Trainer
Resume:
SHANNON NICHOLAS
Quality Systems Specialist & Manager
PERSONAL INFO
**************@*****.***
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
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