Alona Shoe
Woodleaf,NC
Summary
Detail oriented professional with over 11 years of quality control and quality assurance experience working in medical device, 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. Strengths include demonstrated communication skills and high attention to detail, organization, and prioritization of work with limited guidance and management of projects in a timely and effective manner. Strict adherence to ALCOA+ principles.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Regulatory Specialist/ Writer
ITG Brands
09.2023 - Current
- Responsible for the Quality Control of regulatory submissions and developing the timelines and processes for the submissions
- 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.
- Reviewed and analyzed regulatory documents to ensure compliance with applicable laws and regulations.
Remediation Microbiologist I
Cook Medical
03.2022 - 09.2023
- 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
- 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.
- Collaborated with other scientists across multiple disciplines to develop new approaches for solving complex problems.
QC Scientist II
Thermo Fisher Scientific
05.2021 - 03.2022
- 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
- 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
- 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.
- Documented all laboratory activities in compliance with established standards and regulations
- Mentored on processes and procedures relevant to tasks at hand to newly hired employees
Quality Assurance Supervisor
DFA
Winston-Salem NC
05.2020 - 05.2021
- 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.
QC Analyst
Henkel A/G
Salisbury, NC
10.2017 - 05.2020
- 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.
QA Compliance Specialist
Ei, LLC. A Pharmaceutical Solutionworks
Kannapolis, NC
06.2017 - 08.2017
- 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
Ei, LLC. A Pharmaceutical Solutionworks
Kannapolis, NC
01.2015 - 06.2017
- 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
Niagara Bottling, LLC
Mooresville, NC
11.2012 - 01.2015
- Performed testing on raw materials and finished product
- 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
Skills
- Proficient in SAP, SAP Business Objects, Windows Excel, Outlook, Powerpoint, Word; Agile PLM Experience with a variety of Laboratory based data systems: LIMS, SmartLab, Trackwise
- Food Safety Regulations
- Documentation Review
- Environmental Monitoring
- Data Verification
- Technical Guidance
- FDA Regulations
- Technical Documentation
- Project Management
- Document Control
Certification
Clinical Trials Research Associate, Core Competencies Certificate, Durham Technical Community College, 12/2016
Timeline
Regulatory Specialist/ Writer
ITG Brands
09.2023 - Current
Remediation Microbiologist I
Cook Medical
03.2022 - 09.2023
QC Scientist II
Thermo Fisher Scientific
05.2021 - 03.2022
Quality Assurance Supervisor
DFA
05.2020 - 05.2021
QC Analyst
Henkel A/G
10.2017 - 05.2020
QA Compliance Specialist
Ei, LLC. A Pharmaceutical Solutionworks
06.2017 - 08.2017
Microbiologist
Ei, LLC. A Pharmaceutical Solutionworks
01.2015 - 06.2017
Quality Assurance Associate
Niagara Bottling, LLC
11.2012 - 01.2015
Bachelor of Science in Medical Technology -
Catawba College