Quality Assurance

CARLTON PLUMMER

*******.*******@*******.***

https://www.linkedin.com/in/carltonplummer/

Maintaining data integrity and ensuring compliance with company SOPs and specifications, FDA, GLP, QSR and CGMP regulations.

SIGNATURE SKILLS

Clinical Study Planning & Execution Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP)

Regulatory Compliance Standard Operating Procedures (SOPs) Document Control Validation Audit Standards

CAPA (Corrective and Preventive Actions) Measurement Gauges ISO 9001/ISO 17025 21 CFR Part 11/Part 58

Quality Management System Deviations Batch Records Quality Control Inspection Risk Assessment

Regulatory Compliance Training Program Change Control Data Integrity Root Cause Analysis

PROFESSIONAL EXPERIENCE

SOBI PHARMACEUTICALS, INC, REMOTE Feb 2024 – Dec 2024

Quality Engineer (Contractor)

Gathered batch specific documents for clinical releases (e.g., COC, COA, batch genealogy, GMP certification, regulatory submission documentation etc.)

Analyzed data to identify trends and areas for improvement.

Managed quality management systems (Veeva) by initiating change controls, deviations and CAPA as needed.

Ensure compliance with relevant industry standards and regulations (e.g., ISO 9001)

Participate in the development of new products or processes to ensure quality is built-in from the start.

Collaborate with engineering, manufacturing, and other departments to ensure quality standards are met.

FOOD AND DRUG ADMINISTRATION (CDER), REMOTE Feb 2023 – Feb 2024

Quality Assurance Analyst (Contractor)

Successfully migrated 300+ documents to a newly implemented quality management system, Veeva (Quality Docs) to MasterControl (eDMS) by performing quality control within the database and tracking the status of each document.

Spearheaded the creation, implementation, and management of system documentation management within eDMS Document InfoCards.

Developed and updated program documentation, including training resources, standard operating procedures, reference materials, electronic signatures - MasterControl and external (DocuSign), and systems access permissions, enhancing organizational efficiency and knowledge sharing.

Executed comprehensive quality assurance and improvement initiatives, utilizing surveys, workflow studies, reports, and trend analysis to drive continuous enhancement throughout all project phases.

Proactively collected, analyzed, and evaluated quality and performance measurements, identifying negative trends and pinpointing opportunities for process improvements, contributing to overall project success.

Updated training module, ensuring required documents were assigned to appropriate job codes.

BOOZ ALLEN HAMILTON (NIAID), REMOTE Jan 2022 – Sep 2022

Quality Management Specialist (Contractor)

Facilitated a seamless transition of quality and training documents from Veeva to MasterControl Quality Management System (CQMS), ensuring a smooth implementation process and minimizing disruptions.

Played a key role in staff training management, enhancing team competency and proficiency in the utilization of the new quality management system.

Oversaw the maintenance of signature and job description records.

Authored Standard Operating Procedures (SOPs), validation plans, and conducted Installation Qualifications (IQ) and Operational Qualifications (OQ), contributing to the establishment of robust processes and compliance standards.

Led CAPA management efforts, employing root cause analysis techniques and driving process improvements to enhance overall quality and efficiency.

WELLSTAT THERAPEUTICS MANAGEMENT COMPANY, Rockville, MD Mar 2021 – Sep 2021

Administrative Assistant/Document Control (Contractor)

Streamlined document management processes in collaboration with the Quality Director to prepare, submit and archive BLAs, INDs, NDAs, and MAAs documents.

Ensure digital files and physical files are updated to support retrieval.

Improved internal documents accessibility through cell and gene therapy software (WellSky) to enhance efficiency.

Managed reconciliation and archival of records, overseeing comprehensive document lifecycle processes including reviewing and securing storage to ensure compliance and data integrity

AMETHYST TECHNOLOGIES, Baltimore, MD Sep 2015 – Oct 2019

Quality Assurance Specialist

Parent company of Advent Laboratories

Developed quality documentation procedures, maintained testing/lab clean room and equipment, and performed lab tests as needed.

Contributed to the development, implementation, and maintenance of a compliant Electronic Document Management System (EDMS) using FileMaker Pro for USAMRIID, aligning with Good Laboratory Practices (GLP) and Department of the Army regulations.

Executed comprehensive document control procedures, encompassing writing, reviewing, and monitoring the flow of various documents, including standard operating procedures (SOPs), memoranda, policies, and protocols.

Authored, reviewed, and edited diverse documents such as SOPs, validation protocols, policies, and batch records, ensuring adherence to quality standards.

Provided vital support for internal audits and collaborated with other departments to enhance the quality system through continuous improvement initiatives.

Effectively reviewed and managed deviations, corrective and preventative actions (CAPAs), complaints, and Quality Control (QC) investigations.

Maintained a robust quality training program covering areas like GLPs, good documentation practices, cold chain management, and the quality management plan.

Generated internal quality documentation, including quality plans, SOPs, and inspection procedures, contributing to a well-structured quality management system.

Presented weekly status reports to Command and management, showcasing achievements and progress within the quality management framework.

Delivered quality support, including sample pickup and delivery to testing labs, for the Maryland Medical Cannabis Commission (Advent), ensuring efficient and compliant processes.

Perform Quality review of incoming controlled forms (Cleaning logs, Equipment logbooks, records of sterilization, and training forms.

Reviewed and approved supplier quality agreements

Prior Experience:

Sales & Marketing Specialist TBI AUDIO SYSTEMS (SPECTRUM SENSE, LLC), Atlanta, GA

Calibration/validation Specialist CELL SYSTEMS, INC., Silver Spring, MD

Senior Quality Control Analyst WALTER REED ARMY INSTITUTE OF RESEARCH, Silver Spring, MD

Research Associate HUMAN GENOME SCIENCES, INC., Rockville, MD

Associate Scientist II INVITROGEN CORPORATION (LIFE TECHNOLOGIES, INC.), Frederick, MD

Chemist INTRACEL CORPORATION, Rockville, MD

Gas Chromatography Marketing Specialist SHIMADZU SCIENTIFIC INSTRUMENTS, Columbia, MD

Research Chemist U.S. Department of Health & Human Services, National Institutes of Health (NIH), Bethesda, MD)

EDUCATION & CREDENTIALS

B.S., Chemistry – UNIVERSITY OF MARYLAND, Eastern Shore, MD

National Institutes of Health, Fellow

CERTIFICATIONS & TRAINING:

New American Management Association: Time Management course

PUBLICATION:

Published: “Synthesis and nicotinic activity of epiboxidine: An isoxazole analogue of epibatidine.” European Journal of Pharmacology; 321 (2): 189-194 (NIH)

TECHNICAL COMPETENCIES

Operating Systems: Windows, Mac O/S, Linux

Applications: Microsoft Office, MasterControl QMS, Jira, Veeva Quality Docs/Vault, Trackwise, Sharepoint

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