Abigail E.

Dubbs
Home (240)-308-3030 | farkasae10@[Link] | 8150 Lake Norman Place Apt 311, Sherrills Ford, NC 28673
Citizenship: Naturalized U.S. Citizen | Prior Federal Service: No | Veterans’ Preference: No
EMPLOYMENT HISTORY
Quality Engineer, 40 hrs./week July 2024 – November 2024 (Contract – Temporary)
BIC Consumer Product Manufacturing, 5910-D Long Creek Drive, Charlotte, NC 28269
Responsibilities:
• Led the team in achieving ISO 22716:2007 Cosmetic GMP Certification and maintain the certification
each day through practicing GMP.
• Help the team to obtain ISO 9001:2015 certification through updating SOPs in proper format,
understanding the process, and being compliant through conducting internal audits.
• Developed a QSR system for Class 1 Medical Devices and maintained proper documentation control.
Created SOPs, work instructions, and forms to be compliant with the QSR system.
• Maintained an understanding of CFR 820 by working with FDA and registering the facility to produce
medical devices.
• Trained employees in procedures and processes and maintained record keeping.
• Collaborated with each department to better understand processes and improve efficiency.
• I identified, investigated, and reported compliance issues, irregularities, and violations that would be out
of compliance with ISO 22716:2007. Used root cause analysis when applicable.
• Researched industry compliance regulations and policy to better understand what we needed to
improve upon.
• Achieved successful first production run of 50,000 individual medical devices with maintaining record
keeping and documenting each step.
• Assisted in quality assurance checks for incoming material and raw materials.
Quality/Regulatory Affairs Associate, 40hrs./week March 2023 – October 2023
Biocodex, 550 Hills Dr. Suite 200B, Bedminster, NJ 07921
Responsibilities:
• Conducted third party audits, internal audits, and prepared for corporate and FDA audits.
o Prepared the scope of work, summary, and findings for each audit to decide if the facility was in
regulation with our processes and standards.
o Reviewed anywhere between 20-30 SOPs for each facility and adjusted according to updated
processes and findings.
o Used the knowledge of FDA Title 21 CFR to stay compliant within internal audits and FDA
audits.
• Responsible for QMS, training, and staying compliant with SOPs.
o Maintained SOPs for each department by creating an excel timeline and review process.
o The Quality Management System was maintained through updating audit timelines, SOP
revisions, and daily training for each department.
• Execution of effective regulatory reviews and tracking version control of product labeling documents
and outward-facing local/regional to meet regional regulatory requirements and ensure consistency
between labeling, supplement facts, and supportive documents. (US and Canada)
• Ensure compliance in reporting adverse events and documentation to provide the best possible data for
signal detection and response.
o Weekly reporting on adverse events and product complaints ranges from 35-40 reports each
week. Documented and recorded in data management base for record keeping.
• Ensure compliance with global policies and procedures and applicable local vigilance regulation.
• Support artwork and promotional material approval duties for dietary supplements
o Active participation in promotion review committee for all labeling

Farkasae10@[Link] (240)-308-3030
 o Develop, review, approve, and maintain version control of all labeling documents to align with
company goals and requirements for assigned and ensure labeling meets all legal and
regulatory requirements.
• Supports product quality release activities.
o Reviewed and approved batch records for release. Released within 24 hours of receiving and
would review and approve 5-10 each day.

Quality Supervisor/Plant Coordinator, 40 hrs./week – August 2022 to January 2023

UTZ, 238 Industrial Dr. Kings Mountain, NC 28086
Responsibilities:
● Lead and collaborate with team regarding all actions for production runs, including raw materials,
packaging materials, special requests, scheduling and attend all production activities including first runs
and trial runs.
o Created schedule for 12 lines each week by working with logistics on demand. Worked
alongside warehouse to ensure inventory was accurate and had the supplies necessary for
production each day. Maintained a tight schedule by completing all runs in a single shift from
8am-5pm to meet shipping needs.
o Released lines each day through 8-10 allergy and ATP swabs after full sanitation.
● Lead the site’s safety program with responsibility for coordinating safety meetings, gemba walks, and
action tracker lists for repairs, as well as ensuring all safety documentation complies.
o Conduct a safety walk once a month, record any findings, and set up a corrective action plan to
stay within USDA standards.
● Act as Site Level Administrator for Manufacturing Production Systems such as Redzone, Ishidas, and
Canister lines.
o Maintained Redzone runs each day by starting the lines on the systems and logging the data
after each shift. Print and record temperatures and downtime for final report to the USDA auditor
for each run. Ensured proper specification standards to meet SOP and safety standards.
o Managed and understood New Item Setup processes by working alongside process engineers
to understand the Ishida and Canister lines by creating the SOPs and building a troubleshooting
guide for our operators.
● Managed all sample requests (formal and informal) coordinated with Sales, Technical Services and
manufacturing counterparts on all sample requests and coordinated sample deliveries as needed.
● Provide training programs for associates. Maintain current SOPs, training agendas and work
instructions.

UTZ, 3181 Progress Dr. Lincolnton, NC 28092

Responsibilities:
● Ensured quality assurance in everyday tasks and products including:
o Interpreting and reviewing standard operating procedures (SOP’s) to maintain compliance with
regulation and organizational policies, management principles, and departmental policy
requirements for FDA.
o Assisted in an FDA audit by preparing all documentation, revising SOPs and stating the
importance of allergen procedures.
o Held monthly meetings for HACCP and GMP monthly to review practices and compliances.
● Worked closely with other managers to create a safer and more efficient environment.
o Created and implemented new sanitation practices.
o Worked alongside the Production Manager to enforce food safety and review protocols.
o Collaborated with Research and Development on the quality and appearance of new products,
making sure the sensory analysis test passes before fully producing to the market.
o Conducted weekly assessments of allergen testing, including swabbing equipment, staying
updated with new products and ensuring products state allergen present.
Farkasae10@[Link] (240)-308-3030
 o Created non-conforming forms for products that were non-compliance, as well as COAs for our
vendors.
o Report to Director of Quality on any changes in process and updated practices.
● Prepared reports and data that were trended for establishing procedures and changes in productivity.
● Maintained recordkeeping for SQF audits.
● Helped to qualify new products by conducting tests and encapsulating all issues and protocols.

Food Safety Quality Assurance Audit Specialist, 40 hrs./week – January 2022 to June
2022
Dole Vegetables, 220 Southridge Pkwy Bessemer City, NC 28016
Responsibilities:
● Ensured the quality of salad produced product.
o Performed quality tests every 2 hours in an 8-hour shift, conducted quality tests as oxygen,
leak test, puff test, water displacement, and weight test. Maintained a standard of 95% passing
test rate.
o Reviewed consumer complaints by inspecting the situation and regulating the process to
improve future standards.
o Implemented excel and data analysis for daily tasks to include periodic checks in production,
scale mezzanine, box mezzanine, dryer room, trim room, and the perimeter of the building.
o Assisted in swabbing entire facility to discover and destroy Listeria Monocytogenes. Conducted
500-800 swabs in a single shift.
● Interpreted and reviewed standard operating procedures (SOPs) to maintain compliance with regulation
and organizational policies, management principles, and departmental policy requirements for FDA.
o Reviewed 10-15 SOPs each shift for consistency in procedure, updating protocols, and
comparing against FDA standards.
o Reviewed the incoming paperwork from vendors, and ensured product was following PACA
and proper documentation was provided at the time.
o Created and assisted in verifying data and creating charts and graphs that reflect our findings
for managers and plant director. Findings ranging from 1-10 during a single shift.
● Attend, conduct and participate in weekly meetings with production managers, materials managers, and
quality assurance managers to discuss how to be more efficient in our efforts of producing salads for
retailers, as well as proposing changes to coincide with our program.
● Created and instituted training modules for future employees in the Food Safety Quality Assurance
Audit Specialist position that demonstrated the importance of HACCP, Food Safety, and conducting
statistical analyses around the entire process.

EDUCATION and CERTIFICATION

Clemson University, Clemson, SC
Master of Science, December 2021
Major: Food, Nutrition, and Culinary Science
Appalachian State University, Boone, NC
Bachelor of Science, May 2019
Major: Nutrition and Food Systems Management w/ minor in Business
PUBLICATIONS
Farkas, A., (2021). A review of Genetically Engineered Foods. Clemson University.
● PCQI Certification October 2023
● Member of ASQ March 2023
● Lean Six Sigma Green Belt November 2023
● Lean Six Sigma Yellow Belt March 2023
● CPR and First Aid since 2022
Farkasae10@[Link] (240)-308-3030
 ● Pryor Communication and Task Management Certification April 2022
● Food Fraud Prevention Certification May 2022
● Better Process Control School certified since September 2021
● HACCP Certified since October 2021
● Preventive Controls for Human Foods certified since December 2021
● Managers ServSafe, Tennessee since 2019
● Food Science Department Award May 2016

Farkasae10@[Link] (240)-308-3030