Quality Control Assurance

Alona Shoe

Woodleaf, NC ***** *********@***.*** 980-***-****

Regulatory Affairs Chemical, Pharmaceutical, and Food Manufacturing FDA Quality Systems

PROFESSIONAL SUMMARY

Detail oriented professional with over 11 years of quality control and quality assurance experience working in chemical, pharmaceutical, and food manufacturing environments in cGMP, GMP and ISO environments.

Proficiency with FDA Quality Systems (cGMP) and regulatory requirements following the Code of Federal Regulations Title 21 (21CFR).

Well versed in defining problems, collecting, and interpreting data, establishing facts, drawing valid scientific conclusions, and proposing solutions or corrective actions.

AREAS OF EXPERTISE

SAP Business Objects Microsoft Office Agile PLM LIMS SmartLab Trackwise cGMP GMP ISO 21CFR FDA EUMDR

WORK EXPERIENCE

Regulatory Specialist & Writer September 2023 – March 2024

ITG Brands, LLC

The third-largest tobacco company in the US, which offers a broad portfolio of some of the most well-known cigarette, cigar, and e-vapor brands.

Provides support through quality control for the primary regulatory ingredient reporting and other scientific data required for regulatory reporting

Supports Regulatory Science Team through processes surrounding the regulatory submissions and approvals with any entity outside of RSA, including Imperial Group function (Product Science) or legal and regulatory consultants by reviewing regulatory products

Interacts routinely with various internal groups and external consultants (e.g. Corporate Quality, Product Development, Operations, Marketing, and Legal) to ensure all regulatory submissions and responses to the FDA requests for information are properly organized, appropriate, and scientifically accurate and completed in a timely manner

Reviews submissions and other reports of relevant information to the proper authoritative areas and prepares relevant submissions to regulatory agencies by maintaining and utilizing informational databases

Responsible for authoring, organizing, and updating the scientific and technical portions of FDA Premarket Tobacco Applications such as Substantial Equivalence and Exemptions Requests, Tobacco Product Master Files, and Modified Risk Tobacco Product Applications

Remediation Microbiologist I March 2022 – September 2023

Cook Medical

Family-owned medical device company that works with Physicians to develop devices that are less invasive for patients.

Review and interpret FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of medical devices

Performed procedural review and impact/gap assessment of SOP/processes/conduct considering new regulatory intelligence

Performed Microbial Evaluations, utilizing scientific writing, that directly supported EUMDR regulatory filings on Class I, IIA, IIB, Class IIB Implants and Class III medical devices.

Create and/or update technical documentation, programs, and processes as needed to align with EUMDR and standard guidance

Worked with Agile PLM to house change control documents and request feedback on change updates

Used Business Objects and bill of materials (BOMs) to determine various material types and the associated risks during manufacturing

Knowledgeable in the application of international and national standards such as USP, AAMI/ANSI standards, ISO 11737 (Microbial Method), ANSI/AAMI ST72

Administers and oversees internal change control system(s) created Change Control numbers, updated electronic tracking logs, routed documents for review/approval

QC Scientist II, Data Review May 2021 – March 2022

Thermo Fisher Scientific

More than 60 locations globally, end-to-end drug development offerings including API, biologics, viral vector services, cGMP plasmids, logistics services, and commercial manufacturing.

Responsible for ensuring accuracy and integrity of all data reported from Microbiology department as well as data review of wet chemistry data from the Raw Material department

Ensured all raw data and associated documentation adheres to cGMP, GDP, and regulatory conformance, as well as to company SOPs, Compendia (USP, EP) regulations and specifications

Used Trackwise and SmartLab to ensure laboratory testing SOPs were followed and all investigations were notated correctly

Facilitated data and documentation corrections with microbiologists to ensure all records are complete and appropriate references are made

Ensured investigations, excursions are assigned as applicable, completed, and referenced for data as appropriate prior to release of microbiology data

Utilized SAP to store QC testing results and mark products approved for shipment

Reviewed laboratory notebooks, logbooks, and other source data for completeness

Reviewed finished product and/or purchasing specifications against applicable standards to confirm conformance with regulatory requirements

Quality Assurance Supervisor May 2020 – May 2021

DFA

Dairy food product bottling and manufacturing in cooperation with family Farmers.

Reviewed timesheets, payroll, and labor costs for small food lab with total of 6 laboratory personnel

Maintained laboratory inventory of necessary laboratory supplies to ensure adequate stock for daily quality assurance testing of dairy products

Adhered to company policies for cleanliness by enforcing sanitization verification and scheduled sanitization

Provided training for team members on company policies, rules, regulations and job specific duties and responsibilities

Performed environmental microbiological testing to ensure cleanliness during manufacturing of finished goods; monitored and enforced adherence to GMPs and specifications

Ensured food safety and quality records are controlled, accurate, complete, and current

Conducted testing as outlined in Standard Methods for the Examination of Milk Products for: butterfat (FOSS FT-120), total solids (using CEM solids tester), direct microscopic counts, antibiotic content (using Charm ROSA method), sediment testing, standard plate counts and coliform counts as well as yeast and mold counts (using 3-M Petrifilm), pasteurization efficiency (using Charm LumT), titratable acidity on raw milk, cream

Quality Control (QC) Analyst October 2017 – May 2020

Henkel A/G

German chemical and consumer goods company. This site specialized in industrial adhesives with applications in the electronic and automobile industries.

Led the quality lab in 5S activities as group champion for over one year

Performed lab testing utilizing various analytical instruments including: HPLC, GC, GPC, FTIR, UV-Vis, DSC, TGA, as well as auto-titrators, viscometers, rheometers, temperature gauges, performed hardness testing, tensile and compressive testing, appearance and operated and maintained water baths

Executed release and in-process checks by performing testing on various adhesive coatings and peel and shear testing analysis of coatings

Reviewed Certificates of Analysis, Certificates of Compliance, product specifications, and other documentation for completeness and correctness as per applicable procedures to approve or reject product lots

Completed appropriate documentation to support the disposition of product lots

Used SAP to enter sample data, track testing results, and locate products within the warehouse

Quality Assurance (QA) Compliance Specialist January 2015 – August 2017

Ei, LLC A Pharmaceutical Solutionworks

CMO of consumer products, mainly private labels for OTC and Rx drug products and cosmetics as well as animal health products.

Performed Annual Product Reviews for prescribed drug and OTC products

Performed full product investigations based on consumer complaints, including audit/ review of existing batch records, and maintained records for the product complaint system

Supported audits performed by regulatory agencies and external auditing bodies

Communicated with the contract facility/supplier, as warranted, to obtain additional information on complaints and deviation investigations

Tracks closure of complaint and deviation investigations and associated CAPA

Microbiologist January 2015 – June 2017

Conducted safe handling of biological specimens such as bacterial, yeast, and mold specimens

Growth promotion for incoming media for use in the lab.

Performed Microbial Limits Testing per USP 61 and performed Antimicrobial Effectiveness Testing of Category I-IV drug products per USP 51

Conducted environmental monitoring of microbiology laboratory while performing work per company, cGMP and GLP practices

Documented testing and reported results using Good Documentation Practices

Assisted in the review and approval of controlled documents including Standard Operating Procedures (SOPs), forms, organizational charts, specifications, and other related cGMP documentation

Quality Assurance Associate November 2012 – January 2015

Niagara Bottling, LLC

Family-owned manufacturer of bottled water and soft drinks based in Diamond Bar, CA. They produce private label bottled water for several companies.

Performed testing on raw materials and finished product and tracked all data in LIMS

Calibrated and maintained lab equipment

Improved/ revised lab SOPs

Provided training to new QA lab personnel

Investigated aberrant data collaborating with QA Management and departments to resolve issues

Identified and resolved quality issues on production floor, notified maintenance and production supervisor of issues as appropriate

Audited production quality logs for accuracy, consistency, documentation practices followed and ensured product meets relevant quality parameters and worked collaboratively with production personnel on quality issues

Completed non-conforming raw material and corrective action/preventive action (CAPA) claims in a timely manner

Monitored and reported wastewater data using monitoring system and maintained wastewater flow records

EDUCATION

Bachelor of Science in Medical Technology

Catawba College – Salisbury, NC

CERTIFICATIONS

Clinical Trials Research Associate, Core Competencies Certificate December 2016

Durham Technical Community College

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