Collaboration Tools
Carlton Plummer
Quality Assurance Analyst
Summary
Solution-oriented Quality Assurance Specialist with 30 years of broad biotechnology industry experience, ranging from research chemistry, production, and regulatory compliance, offering expertise in diverse quality functions. Proven proficiency in software and hardware testing, analytical quality control (QC), and verification of system and document changes. Conduct thorough quality audits to ensure compliance with established guidelines. Instrumental in assuring integrity of laboratory QA, QC, and proficiency practices within the framework of rigorous QA program guidelines. Experienced in coordinating and managing laboratory activities, contributing to a culture of excellence and adherence to quality standards.
Overview
25
25
years of professional experience
3
3
years of post-secondary education
Work History
Quality Assurance Analyst
Food and Drug Administration (CDER)
2 2023 - 02.2024
- Assisted the agency with maintaining, updating program/project management plans and associated documents
- Prepared, submitted, implemented, managed, maintained, and updated a detailed Quality Control Plan (QCP) that documents the methodology, standards, and acceptance criteria to verify that delivered products/services for all work under the Statement of Work SOW and individual orders satisfy contractual agreements, meet client quality standards, and comply with project-specific processes and requirements
- Develop and periodically update program documentation such as training resources, standard operating procedures, and other reference materials
- Perform quality assurance reviews on contractual and ad-hoc deliverables or documents
- Implement all phases of quality assurance and improvement by utilizing surveys, workflow studies, reports, and trend analysis
- Collect, analyze, and evaluate quality and performance measurements to identify negative trends and potential process improvements opportunities.
Quality Management Specialist
Booz Allen Hamilton (NIAID)
01.2022 - 09.2022
- Supported in the transition from EDRMS to MasterControl quality management system (CQMS)
- Compiled research data and gave professional presentations highlighting finds and recommended optimizations.
- Gathered, documented, and modeled data to assess business trends.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Assisted in CAPA management, root cause analysis and process improvement.
- Streamlined production workflows by collaborating closely with cross-functional teams to identify areas for improvement.
- Ensured regulatory compliance by conducting thorough audits and providing guidance on necessary corrective actions.
- Supported continuous improvement initiatives, resulting in significant cost savings and process optimizations.
- Boosted overall operational efficiency with the introduction of new quality management tools and methodologies.
- Created and optimized records management strategies to coordinate and protect information.
Administrative Assistant/Document Control
WELLSTAT MANAGEMENT COMPANY
03.2021 - 09.2021
- Assisting Quality Director with document management
- Managed filing system, entered data and completed other clerical tasks.
- Performed research to collect and record industry data.
- Improved document organization with thorough file maintenance, archiving outdated records as necessary for efficient retrieval when needed.
Sales and Marketing Specialist
Spectrum Sense, LLC
11.2019 - 03.2021
- Coordinate and support the development of communication tools and collateral to promote new features, functionality, and services to both prospects and existing clients
- Support the content team (managers/owners) in the creation of cross-selling products (marketing tool)
- Stayed current on company offerings and industry trends.
- Organized and managed successful trade shows, expanding the company''s professional network and generating new leads.
- Developed relationships with retail and social awareness businesses.
- Contributed to event marketing, sales and brand promotion.
Quality Assurance Specialist
AMETHYST TECHNOLOGIES
09.2015 - 10.2019
- Assisted in development, implementation, and maintenance of an EDMS (FileMaker Pro) for USAMRIID (Frederick, MD) compliant with good laboratory practices (GLP), and Department of the Army regulations
- Conducted document control procedures including writing, reviewing, and tracking and monitoring the flow of all documents including, standard operating procedures (SOPs), memoranda, policies, and protocols
- Recorded and organized test data for report generation and analysis.
- Updated inspection journals and daily summary logs with quality-related data.
- Interfaced with other departments on continuous improvement of the quality system
- Maintained the quality training program that included the following areas: GLPs, good documentation practices, cold chain management, quality management plan, etc
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Assessed products or services to evaluate conformance with quality standards.
- Ensured product compliance with industry regulations by staying up-to-date on relevant standards and guidelines, implementing necessary changes to maintain conformance.
- Generated internal quality documentation such as quality plans, standard operating procedures, and inspection procedures
- Presented annual status reports to Command and management
- Provided quality support (sample pickup and delivery to testing lab) for the Maryland Medical Cannabis Commission (Advent).
Bakery Manager
SAFEWAY
09.2011 - 08.2014
- Works with co-workers as a team to ensure customer satisfaction and a pleasant work environment
- Perform all other related duties as assigned by senior management
- Assign work to, direct the work of and train Department personnel
- Manage department operations in accordance with established department standard practices
- Ensure that associates perform their work in a safe and ergonomically correct manner
- Develop and lead a retail sales team to provide customer service at the highest level in all areas
- Works with other department managers and teams to effectively deliver results.
- Oversaw all aspects of quality control to maintain consistently high standards for baked goods produced at the facility.
- Monitored inventory levels and identified opportunities for cost savings.
- Researched issues to obtain appropriate answers to customer inquiries.
- Decreased inventory shrinkage, drive-off and daily cash discrepancies by closely monitoring daily operations.
Sales and Marketing Specialist
TBI Audio Systems
8 2006 - 8 2011
- Organized and managed successful trade shows, expanding the company''s professional network and generating new leads.
- Built relationships with customers and community to promote long term business growth.
- Increased brand awareness by creating engaging social media content and managing online platforms.
- Maintained current knowledge of evolving changes in marketplace.
- Developed relationships with audio manufacturers and retail businesses.
- Contributed to event marketing, sales and brand promotion.
- Promoted conversion of casual shoppers into customers through product knowledge and product solutions to meet customer needs.
Calibration/Validation Specialist
Cell systems, inc
06.2004 - 05.2005
- Executed calibrations for laboratory equipment
- Assisted with the execution of temperature mappings of storage units
- Tested the functionality of equipment and performed measurements for accuracy, sensitivity, and selectivity
- Performed preventative maintenance and repairs on laboratory equipment.
Senior Quality Control Analyst
Walter reed Army Institute of research
04.2002 - 05.2004
- Conducted protein application testing (vaccines)
- Performed USP chemistry testing of water systems in the facility
- Performed environmental monitoring of clean rooms
- Conducted performance qualification/operational qualification of analytical instruments
- Established and reviewed standard operating procedures for the laboratory
- Developed method and validation for clean rooms and laboratory equipment
- Followed Good Manufacturing Practice/Good Laboratory Practice guidelines and procedures, ISO 9000
- Trained 4 quality control technicians in environmental monitoring procedures and testing
- Reviewed data finds and charted trends of environmental particulates.
Research Associate
Human Genome Sciences, Inc.
09.2001 - 02.2002
- Performed protein formulation and application testing
- Quality checked testing of time and temperature stability samples
- Collaborated with researchers and scientists to design and execute experiments.
- Coordinated and managed laboratory projects and experiments.
- Interpreted laboratory results to provide technical advice to scientists.
- Developed data collection strategies and monitored data quality for optimal research results.
Associate Scientist II
Invitrogen Corporation (Life Technologies, Inc.)
11.1998 - 09.2001
- Quality control check of products throughout manufacturing and scale process..
- Maintained compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines.
- Participated in research projects by designing and executing experiments.
- Collaborated with cross-functional teams for successful completion of projects, meeting deadlines and objectives.
- Prepared samples for analysis by performing complex sample preparation tasks.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Conducted experiments in laboratory environment for product development purposes.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Analyzed results using analytical software and created reports.
- Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal.
- Assessed project requirements against current GMP, GLP and EHS standards and practices.
Chemist
Intracel corporation
06.1998 - 10.1998
- Performed specific Fourier Transform Infrared Spectroscopy (FTIR) applications to meet GC specific requirements
- Maintained radiochemistry laboratory and equipment including FTIR, Nuclear Magnetic Resonance, and Liquid Chromatograph
- Synthesized a patented chelate for further product production.
Gas Chromatography Marketing Specialist
Shimadzu scientific instruments
08.1997 - 02.1998
- Assisted in preparing gas chromatography (GC) and gas chromatography mass spectrometry (GCMS) instruments for demonstrations and courses
- Performed specific GC/GCMS applications to meet customer specific requirements
- Prepared product release packets for the GC/GCMS instruments and accessories.
Research Chemist
National Institute Of Health, NIDDK
1 1994 - 1 1997
- Provided bio-organic chemistry support in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) pharmacodynamics laboratory
- Performed instrumental analysis nuclear magnetic resonance spectrometry (NMR), a continuation of mass spectrometry and infrared spectrometry in vapor phase (GC-MS-FTIR) of frog skin alkaloid extracts
- Synthesized natural products and derivatives for research.
- Modified and adapted standard methods and procedures to solve analytical problems.
- Carried out laboratory tests and experiments to analyze, identify and isolate chemical compounds.
- Contributed to patent applications and publications by providing crucial data analysis and interpretation.
Education
B.S. - Chemistry
University of Maryland
Eastern Shore, MDInternship
National Institutes of Health
Bethesda, MD 1995 - 1997
Skills
Teamwork and Positive Attitude
Time Management
Database testing proficiency
ISO 9001
Active Listening
Adaptability and Flexibility
FDA regulations
Software Release and Versioning
QMS
Developing Quality Standards
Critical thinking abilities
Data Analysis
Attention to Detail
Analytical Thinking
Root Cause Analysis
Adaptability
Product Development
Software Development Tools: JIRA, Confluence
Issue Resolution
Problem-Solving
Interpersonal Skills
SharePoint
Accomplishments
- Published: “Synthesis and nicotinic activity of epiboxidine: An isoxazole analogue of epibatidine.” European Journal of Pharmacology 1997 FEB 26; 321 (2): 189-194 (NIH)
- Synthesized a patented chelate (Intracel)
Software
Database
Data Analytics
Microsoft Teams
Microsoft Office Suite
EDMS
Timeline
Quality Management Specialist
Booz Allen Hamilton (NIAID)
01.2022 - 09.2022
Administrative Assistant/Document Control
WELLSTAT MANAGEMENT COMPANY
03.2021 - 09.2021
Sales and Marketing Specialist
Spectrum Sense, LLC
11.2019 - 03.2021
Quality Assurance Specialist
AMETHYST TECHNOLOGIES
09.2015 - 10.2019
Bakery Manager
SAFEWAY
09.2011 - 08.2014
Calibration/Validation Specialist
Cell systems, inc
06.2004 - 05.2005
Senior Quality Control Analyst
Walter reed Army Institute of research
04.2002 - 05.2004
Research Associate
Human Genome Sciences, Inc.
09.2001 - 02.2002
Associate Scientist II
Invitrogen Corporation (Life Technologies, Inc.)
11.1998 - 09.2001
Chemist
Intracel corporation
06.1998 - 10.1998
Gas Chromatography Marketing Specialist
Shimadzu scientific instruments
08.1997 - 02.1998
Internship
National Institutes of Health
1995 - 1997
Quality Assurance Analyst
Food and Drug Administration (CDER)
2 2023 - 02.2024
Sales and Marketing Specialist
TBI Audio Systems
8 2006 - 8 2011
Research Chemist
National Institute Of Health, NIDDK
1 1994 - 1 1997
B.S. - Chemistry
University of Maryland