Project Management Quality Systems
Resume:
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E D U C A T I O N
Degree Granting Programs
Bachelor of Science
Microbiology/Biotechnology
Minor Chemistry
Delaware Valley University of
Science and Agriculture
Doylestown, PA
August 2004- May 2008
University of Washington
Certificate in Biotechnology
Project Management
Sept. 2025-May 2026
Online Non-Degree Courses
Certified Six Sigma White &
Yellow Belt (+ Excel Application)
Udemy.com
P R O F E S S I O N A L A C C O M P L I S H M E N T S
• At a small Biotechnology Company, I brought the Quality Department back to a necessary standard.
• Trained employees on GxP’s and contamination by creating SOPs for the Laboratory and for the Quality process.
• At an International Food Manufacturing Company, I was a leader in investigating and eliminating their Listeria contamination.
• Audited and overhauled the Quality and CAPA Departments of an International Food Manufacturing Company, new to the U.S., and an established Biotechnology Company.
• Created SAP Catalogue, which was used in improving Vendor Relations. The catalogue included a Certificate of Analysis and a Checklist of acceptable parameters for vendor perishable goods shipments.
• Trained 500+ employees on topics such as aseptic technique, GMPs, and cross-contamination in English and Spanish.
• Created a pamphlet that both employees and customers could use to understand the processes of Monoclonal and Polyclonal Antibody manufacturing, understand the different options available for production and final state.
• Spoke at the United Nations in support of Women’s Rights S HANNON N I CHOLAS
Q u a l i t y S y s t e m s & T r a i n i n g S u p e r v i s o r P R O F E S S I O N A L E X P E R I E N C E
INT Investigations Specialist
Moderna Therapeutics Norwood, MA. May 30, 2023- Aug. 15, 2025 Part of a cohesive team responsible for producing high-quality mRNA-based medicines for commercial production and evaluation in human clinical trials, specializing in personalized cancer vaccines. The manufacturing specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support day-to-day operations through deviation and CAPA writing and projects with a focus on, but not limited to, DNA, mRNA, or fill-finish operations. Position is M/F, sometimes outside of working hours to support 24/7 production.
Key Responsibilities
• Utilizing Manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events.
• Lead cross-functional teams to drive complex investigation closeouts, determine root causes, and implement appropriate corrective & preventative actions.
• Conduct document revisions and/or document management including batch production records and manufacturing processes.
P E R S O N A L
I N F O
****************@*****.***
https://www.linkedin.com/in/
shannon-nicholas
73 Brookside Ave.
West Warwick, RI 02893
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S HANNON N I CHOLAS
P R O J E C T M A N A G E R & Q U A L I T Y M A N A G E R P R O F E S S I O N A L E X P E R I E N C E C O N T I N U E D INT Investigations Specialist Continued
Moderna Therapeutics Norwood, MA. May 30, 2023- present
• Participate in user forums for gathering ongoing requirements, prioritization, and triage issues.
• Follow-up on requests, issues, and projects and report statuses to managers/working teams.
• May perform metric trends.
• May generate technical protocols and reports.
• Work independently with minimal supervision.
• Perform work that consistently requires independent decision making and exercise independent judgement and discretion.
Quality Specialist Coordinator
Thermo-Fisher Scientific Allentown, PA June 2022 – June 2023 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 so they can 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 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 done
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 post review as a Quality Specialist. K e y S k i l l s
Quality
Problem Solving
Leadership
Training Skills
L a n g u a g e s :
Spanish:
Read:
Write:
Speak:
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P R O F E S S I O N A L E X P E R I E N C E C O N T I N U E D 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
o Root Cause Analysis Tools
5 Why’s, Fishbone
o ALCOA+
• Training staff on Quality Systems computer programs used to initiate quality process. o eQRMS, Infinity
o Aided Senior Managers in the Quality
• Systems Group with daily tasks.
o CAPA metrics and reports; APQR
o Reviewing Deviations and CAPA’s
o Running 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
o Customer Complaints.
o All Reports.
o Investigations
o Change control.
A d d i t i o n a l S k i l l s
• 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
• IBM Maximo
• Internal Audit
• Internet Research
• ISO 9001
• Lean Six Sigma
• LIMS
• Management: Lab & Quality
• Manual Lab Testing
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P R O F E S S I O N A L E X P E R I E N C E C O N T I N U E D Lab Manager & Head of Quality/ Lead Immunochemistry Researcher Continued PRF&L Canadensis, PA March 2019- June 2019
• Head Of Micro & Quality
o Environmental Monitoring with Aseptic technique. o Trained employees in Aseptic Technique
o Lead quality control and micro testing throughout the facility.
• Led all IgG production, investigations, testing, purification, and reports.
• Purifications using column chromatography.
o Ultralink
o Sulfalink.
• Antigen conjugation also with column chromatography to elicit an immune response o with KLH or BSA.
o Maleimide
o Small molecule (BSA)
• Protein purification,
o IgA, 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. o Used various adjuvants and buffers to create mixture
• Used a wide variety of other scientific techniques for investigations and research especially:
o ELISA, 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. Recieval of
Peptide
Antigen
Conversion if
no Immune
Response
Creation
of
Injection
Injection of
Chosen
Vertebrate
Monoclona
l Antibodies
Euthanization Dissection
of Spleen
Sent to Client in
Antibiotic &
Antifungal Broth
Polyclonal
Antibodies
Multiple
Bleeds
Depending
upon Chosen
Proc.
Final Bleed &
Exanguination
Purificatio
n of
Specific
IgG
Confirmation of
Antibodies
Dialysis
Liophylizatio
n
ELISA
Mass Spec.
Ultralink
Sulfalink
KLH
BSA
A d d i t i o n a l S k i l l s
C o n t i n u e d
• Mass Spec
• Metrics
• Microscopy
• Microsoft Office
• OsiPi
• 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
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P R O F E S S I O N A L E X P E R I E N C E C O N T I N U E D 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
o Established qualifications for incoming raw materials.
• Led Environmental Monitoring and Aseptic technique in clean room environment.
• Bioburden testing.
• Review all paperwork for Quality Department.
o Input all results into a LIMS type system.
o Create reports for Out of Spec. batches
o Provide 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. o Received customer complaint and spoke to customer. o Investigated complaint
o Created Customer Complaint and Investigation reports o Corrective actions to address the deviation
o Led 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: o creation of specs and requirements for materials, o logging and evaluating all COA's,
o determining acceptability of material by creating specific parameters for the pass/fail of shipment.
• . Created Raw Material Binder which included
o Each raw material
o Vendor Sending raw material
o COA and specifications for pass/fail
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P R O F E S S I O N A L E X P E R I E N C E C O N T I N U E D
• Managed 11-14 QC/QA techs on three shifts.
• Presented all Quality Lessons for building in English and Spanish.
• Worked with finance department:
o For any matters regarding Quality and R&D Departments. o ITR's all paperwork,
o Balanced budget in Syspro and AP Smart
• Communicated regularly with the USDA and FDA on label creation, product release. o Versed 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 o sub-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.
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Oop
Office Manager
P R O F E S S I O N A L E X P E R I E N C E
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,
o ICP-AES,
o Graphite Furnas,
o and 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.
o Test for confirmation of species for E. coli sub-species and Listeria species.
• Used Vidas 1 and other instrumentation to test samples. Receipt of EM or
Sterility Sample
Streak sample on Agar
Plate for First Phase of
ID
Sub Culture and streak
on Various Agars to
further ID microbes
present in sample
Bacteria
Gram Stain
Catolase and Oxidase
Tests Performed
ID bacteria in Vitek.
Card used depends on
Results
Microdase and Indole
Tests Performed
Test all Microbes on
Vitek Except Indole
Negative bacteria.
Fungus
Draw what is observed
under microscope.
ID based on book
pictures and discription
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V O L U N T E E R E X P E R I E N C E
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 o Licenses necessary for cargo
IE. Live cargo, pharmaceutical products, etc.
• Customer Relation Training
o Receiving Payment; Late Payment
o Late Delivery or Non-Delivery
o Lost Cargo
• Rules & Regulations for U.S. international exports o Customs-Trade Partnership Against Terrorism (C-TPAT) o Authority and Terminal Operator (MPTO)
o Warsaw Convention
o Many more
Contact this candidate