REGINALD COLE

Baltimore, Maryland

443-***-****

ac7gfv@r.postjobfree.com

WORK EXPERIENCE

Chemist (II) at Advent Laboratories, Baltimore, MD Mar. 2017 – Jun. 2018

Worked under strict GLP and cGMP environment to build up Advent Lab from an abandon lab.

ISO Proficiency testing by validating of GC MS, GS-HS-FID, HPLC and ICP-MS instruments

ICP-MS used to analyze for Heavy metals, data processed and reported.

HPLC assay on cannabis potency.

Volatile matter detected on the Headspace GC-FID.

Terpene and pesticides analysis ran on the GC-MS

HPLC software chemstation, openlab.

GC and ICP software, masshunter and chemstation.

Water Activity and percent moisture using Aqualab software.

Prepared all linearity curves, reagents, mobile phase solution and sample preparation.

Identify and implement opportunities to improve laboratory efficiency.

Orders laboratory supplies and recommend the acquisition of new equipment.

Cleaning and preventative maintenance of various Instruments

Good documentation using templates and laboratory notebook.

Responsible for all aspects of data collection, review and reporting.

Interviewed future employees and member of the hiring team.

Constantly training and updating skills.

Microsoft proficient.

Analyst at AptarGroup, Baltimore, MD Oct. 2014 – Dec. 2016

A full-service cGMP compliant laboratory in analytical testing.

ISO Proficiency testing by HPLC assay

Operated the coulometer to determine moisture in the USP Standard

Prepared, collected and analyzed samples

HPLC assay on USP standards, client API and placebos.

Troubleshoot HPLC, wrote Incidence and Deviation Reports leading to Corrective and Preventive Action.

Checked and reviewed data, worked with Quality Assurance to expedite release of data after audited.

Performed and document method transfer from Analytical Development.

Assisted in FDA, ISO and client’s audits.

HPLC uses, using Empower 2 software. processed data and data entry into verified excel sheets.

Method validation, method verification, stability testing and bioequivalence studies were conducted.

Participated in 5S, kaizen and peer recognition program

Detailed work documentation, using my created templates tape and sign into work notebook.

Aerotek Scientific LLC (Temp Agent) at AptarGroup, Baltimore, MD May 2013 – Oct. 2014

Tested pump delivery, particle size, begin and end of life of spray and spray pattern.

Proficient using Malvern Spraytec STP2000 and SprayView NSx

Program test method in the Viola and Spraytec software.

Wrote and signed controlled documents such as reports, protocols and test methods.

Perform HPLC using Hitachi Elite LaChrom using EZChrom software for processing.

Prepared diluent, standards and mobile phase for instrument

Test Method and Study Protocol were followed and written.

Analytical Chemist (II) at the Medical Examiner’s Office, Wilmington, DE Feb. 2010 – Oct. 2012

Worked under strict cGLP and cGMP environment.

Tested biological samples for the presence of drugs and alcohol to determine cause of death or driving under the influence (DUI).

Read and followed Standard Operating Procedures (SOP’s) and laboratory policies.

Received log and stored in secured refrigerator, biological evidence for testing.

Performed daily, weekly and monthly maintenance on the GC-MSs and troubleshoot when necessary.

Fluent in Agilent ChemStation and MassHunter quantitation software for quantifying and data processing.

Performed solid-phase extraction (SPE) and solid supported liquid–liquid extraction (SLE).

Derivatized compounds as needed.

Processed alkaline drug and acid neutral extraction data using Agilent Deconvolution Reporting Software (DRS) and Agilent Automated Deconvolution and Identification System Chromatogram (AMDIS).

Ran Alcohol analysis using Headspace GC-FID.

Performed periodic proficiency tests from CTS, CAP and NHTSA.

Trained to provide expert testimony in court.

Maintained and back up the Instrument computer system.

Participated in FQS audit for the maintenance of the Lab accreditation with ISO 17025 Standards, where ISO is the International Organization for Standardization.

Kept up with emerging trends, regulations, techniques and technology in the Analytical field.

Independently put forth effort needed to accomplish assignments, consistently produced completed and accurate work within deadlines.

Maintained the highest level of quality assurance and quality control when performing sample analysis and reviewing case results.

Assisted with and/or worked independently on extra projects, which so included, but were not limited to, validating instrumentation and/or methods, inventorying / cleaning / organizing, and updating databases.

QC Chemist at Mutual Pharmaceutical Company, Inc. PA. Sept. 1993 – Aug. 1994

Analyzed raw materials; in-process and final products for both release and stability testing.

Methods used were the United States Pharmacopeia (USP), in-house or European Pharmacopia (EP) procedure.

Strictly adhered to SOP’s and cGMPs.

Conducted Method Validation, Dissolution, Content Uniformity, Disintegration, HPLC Assay, TLC, Heavy metals, Arsenic and Lead analysis.

Prepared mobile phase, diluent, dissolution media as per protocol.

Operated the dissolution baths, IR, Karl Fischer and Cary 50 UV\VIS spectrometer.

Developed Quattro-pro report spreadsheet for use in the laboratory.

QC Chemist at Unilever in Baltimore MD. Feb. 1991 – Dec. 2005

Worked under strict cGLP and cGMP environment.

Analyzed in-coming raw materials.

Reviewed Certificate of Analysis before materials were unloaded.

Qualitatively tested in-process and final products to make sure products’ cosmetic appearance, odor and color conformed to Unilever standards.

Conducted chemical, analytical, and instrumental testing.

Prepared reagents, prepared and ran standard solutions.

Monitored enzyme, air, and dust levels daily using Cobas Mira Spectrophotometer.

Tested the amount of grease and oil in the effluent.

Instructed Chemists on the proper use and maintenance of the PerkinElmer FT-IR.

Participated in drafting new SOP's and policies.

Performed in-depth lab investigations of non-complying test results.

Operated the Densitometer, Karl Fischer Titroprocessor and MacBeth Colorimeter.

Ordered and stocked chemical supplies.

Quantitatively and cosmetically checked the final shipping products.

Assisted with and participated in production meetings, especially root cause analysis investigation.

Documented and calculated results. Entered all results in Systems Applications and Productions (SAP) system.

Communicated with manufacturing regarding the analytical results and/or recommended solutions to fixing out-of-specification results.

Lead and instructed junior Chemist and Lab Techs.

Inspected, audited products at local stores and supermarkets.

Maintained Data integrity and appropriate traceability.

Participated in laboratory quality assurance and quality control programs.

EDUCATION

Towson University, Towson, MD Jan. 1991

Achieved an American Chemical Society accredited, Bachelor of Science degree in Chemistry

Additional Training:

Seminars Attended

Tuning your ICP Instrument for excellent sensitivity and long term stability (05/18) Baltimore, MD.

The Essentials guide to GC/MS MassHunter software (03/18) Baltimore, MD.

Fundamentals of ICP-MS analysis and its Applications for low level elemental determination in Cannabis. (4/17) Baltimore, MD.

Cannabinoid profiling by HPLC-DAD and single quadrupole Mass Specctrometry (04/17) Baltimore, MD.

Agilent MassHunter Boot Camp 2017 (04/17) Baltimore, MD.

Aptar. cGMP training; 21 CFR Part II Compliance and data integrity (11\15) Baltimore, MD.

Waters Corp. Convergence Chromatography and Supercritical Fluid Extraction. (11/12) Columbia, MD.

RTI International. Fundamentals of LC/MS/MS. (09/12) OCME, DE.

Agilent Technologies. LC Master Class. (09/12) Wilmington, DE.

RTI International. Expert Testimony Training for the Prosecutor and Scientist II. (09/12) OCME, DE.

RTI International. Analytical Methods in Workplace Drug Testing – Sample Preparation. (09/12) OCME, DE.

Waters Corp. Utilizing UPLC Mass Spectrometry in the Forensic Toxicology Laboratory (07/11) OCME, DE.

Shimadzu Corp. LCMS Triple Quadrupole Mass Spectrometer. (06/11) Columbia, MD.

Expert Testimony Training for the Prosecutor and Scientist. (10/10) OCME, DE.

Supelco Inc. Basic GC and Troubleshooting. (10/10) OCME, DE.

PerkinElmer's Blood Alcohol Content by Headspace/Gas Chromatography. (09/10) OCME, DE.

Credibility is Believability: Success in the Courtroom. (07/10) OCME, DE.

Waters Corp. Developing Robust LC Methods. (06/10) New Castle, DE.

Agilent Technologies GCMS, Optimizing Inlet, Productivity tool kit & which MS best fits your lab. (03/10) Baltimore, MD.

Amtek Inc. Hands on telephone, internet, wireless and cable installation for Comcast customers. (01/10) Baltimore, MD.

ComputerTraining.com: Microsoft Certified Systems Engineer Training Program and cabling course. (07/07) Towson, MD.

PerkinElmer. Three days Training Course: Introduction to FT-IR, Spectrum software and Sample preparation. (04/05) Shelton, CT.

Contact this candidate