Quality Document Control

CARLTON V. PLUMMER

Analysis • Accuracy • Quality Control • Research • Quality Assurance

EXPERIENCED RESEARCH CHEMIST & QUALITY ASSURANCE SPECIALIST

…committed to scientific accuracy and data-driven results

Biochemistry

Physical chemistry

Environmental chemistry

Audit standards

Measurement gauges

Acceptance sampling and control charts

Process protocol and process control

Quality control inspection

Lean Six Sigma/ ISO 17025

Small to large laboratories

Modern laboratory equipment

HIGHLIGHTED CHEMISTRY AND QUALITY EXPERIENCE

Quality Assurance Specialist

AMETHYST TECHNOLOGIES, BALTIMORE, MD 2015- 2019

(Parent company of Advent Laboratories)

Assisted in development, implementation, and maintenance of a quality system 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.

Wrote, reviewed, and edited documents (SOPs, validation protocols, policies, batch records.).

Provided internal audit support.

Interfaced with other departments on continuous improvement of the quality system.

Reviewed deviations, corrective and preventative actions (CAPAs), complaints, and QC investigations.

Maintained the quality training program that included the following areas: GLPs, good documentation practices, cold chain management, quality management plan, etc.

Generated internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.

Presented annual status reports to Command and management.

Assisted in providing quality support (sample pickup and delivery to testing lab) for the Maryland Medical Cannabis Commission (Advent).

SAFEWAY, ROCKVILLE, MD 2011-2014

Bakery Manager/Night Stocker

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 Chef team to effectively deliver results

TBI AUDIO SYSTEMS (SPECTRUM SENSE, LLC), ATLANTA, GA 2006-2011

Sales and Marketing Specialist

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)

Presented brand and audio technology at trade shows

Developed relationships with retail businesses

CELL SYSTEMS, INC, Silver Spring, MD 2004-2005

Calibration/Validation Specialist (Temp)

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

WALTER REED ARMY INSTITUTE OF RESEARCH, Silver Spring, MD 2002-2004

Senior Quality Control Analyst

Conducted protein application testing (vaccines).

Performed USP chemistry testing of water systems in the facility.

Environmental Monitoring of clean rooms

Conducted performance qualification/operational qualification of analytical instruments.

Established, updated 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

HUMAN GENOME SCIENCES, INC., Rockville, MD 2001-2002

Research Associate (Temp)

Performed protein formulation and application testing.

Quality checked testing of time and temperature stability samples.

Developed method for determining the actual concentration delivered through a nebulizer.

INVITROGEN CORPORATION (LIFE TECHNOLOGIES, INC.), Frederick, MD 1998-2001

Associate Scientist II

Produced transfection reagents, resins, and protein ladders (GMP) .

Performed specific analytical applications including chromatography and electrophoresis.

Quality control check of products throughout manufacturing and scale process.

INTRACEL CORPORATION, Rockville, MD 1998

Chemist (Temp)

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.

SHIMADZU SCIENTIFIC INSTRUMENTS, Columbia, MD 1997-1998

Gas Chromatography Marketing Specialist (Temp)

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.

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH, Bethesda, MD 1994-1997

Research Chemist

Provided bio-organic chemistry support in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) pharmocodynamics 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.

EDUCATION

B.S., Chemistry, University of Maryland, Eastern Shore, MD – 1995

National Institutes of Health, Fellow – 1997

ACCOMPLISHMENTS & CERTIFICATIONS

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)

Agilent Technologies: Advanced Chemstation course – April 2003

HPLC 3D Chemstation Data and Analysis – November 2003

New American Management Association: Time Management course – October 2002

COMPUTER & TECHNICAL SKILLS

Operating Systems: Windows, Mac O/S, Linux

Applications: Microsoft Office, Microsoft Project, TOC Talk, Waters Millennium, Agilent Chemstation

Analytical Instruments: Varian EM600 NMR,EM360L NMR: Finnigan Mat GC/MS/MS (with direct probe): Hewlett Packard: GC/IR/MS (in series), Waters/Agilent HPLC: RP,SEC; Perkin-Elmer: Lambda 4B UV/VIS Spec, 1600 Series FTIR; Shimadzu Scientific Instruments: GC/GCMS, TLC; Parr Hydrogenation apparatus; Biotage: Flash chromatography instruments; Labconco: LyphLock 6 Freeze Dry System, Bio-Rad, Millipore Milliflex, Milliflex Plus), Phoenix 8000 TOC Analyzer

Protein Assay: Gel Electrophoresis: SDS-Page, Silver Stain, BCA, OD A280, HPLC, Biorad Microtiter Plate, DC Biorad

Endotoxin Assay: Limulus Amebocyte Lysate Gel Clot Test

Residual Assay: Detecting Phenols, Chlorine, Formaldehyde

TOC: Determination of Total Organic Carbon

Appearance: QC Bulk and Final Lot Evaluation

USP Chemistry Testing: pH, conductivity

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