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Analytical Chemist, HPLC, UPLC/Qda, GMP, Laboratory Scientist, QA, QC

Location:
Pearland, Texas, United States
Posted:
January 30, 2019

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Resume:

LATOYA BURKETT

**** ******** *****, ********, ** 77584 • 501-***-**** • ac8cc2@r.postjobfree.com

PROFESSIONAL SUMMARY

A GMP-certified pharmaceutical manufacturing quality analytical chemistry professional with 19 years of experience in regulated laboratories and process improvement. Experienced in lab startups, analytical chemistry, auditing, method development/validation, procedure writing, training, UPLC (Reversed Phase and HILIC), and quality assurance/control.

SKILLS

Laboratory startup Equipment: UPLC, HPLC, Ion Chromatography, Analytical Chemistry Laboratory Management Gas Chromatography Laboratory and Quality System Auditing Staff safety/GMP training and development Software: Chemstation, LabSolutions, Empower 1,

2, and 3

WORK HISTORY

Chemistry Laboratory Manager

Avella Specialty Pharmacy - Houston, TX 12/2016 - 2019 Performed data analysis and provided recommendations to bring over 90% of potency/ID testing in-house.

Served as chemist, laboratory supervisor, laboratory manager, and facility manager. Responsible for analytical methods development and instrumentation needs for potency testing of IV drugs.

Authored and/or reviewed OOS investigation reports, analytical protocols, SOPs, and technical reports. Planned laboratory construction and setup operations. Developed and validated laboratory HPLC, UPLC, UHPLC-UV and Ion Chromatography methods. Hired, trained, scheduled hours, supervised and coordinated the work of laboratory employees on projects.

Quality Assurance Manager

Celltex Therapeutics - Houston, TX 09/2015 - 12/2016 Review and improve stem cell production quality system documentation; write and/or review Quality Assurance (QA) standard operating procedures to assess cGMP compliance on issues relating to sterile biologics manufacturing. Provide interpretation of GMP/GTP/GCP regulatory requirements as they apply to Celltex. In charge of OOS and deviation reporting program. Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites. Supervise the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products. Conduct weekly quality review meetings and prepare reports. Develop and conduct GXP and safety training courses for all staff annually, post-audits, and as necessary, and maintain staff GMP training records.

Quality And Chemistry Laboratory Manager

Control Solutions, Inc - Pasadena, TX 07/2013 - 09/2015 Established all SOPs for safety, end product quality assurance, QC/analytical chemistry laboratory, and company quality policy.

Partnered successfully with Regulatory, Production, Purchasing, and Corporate to reduce customer complaints.

Trained, coached and mentored staff to ensure smooth adoption of new quality laboratory and QA line audit program.

Developed a Quality Manual which describes the company quality management system and outlines the quality policy.

Supervised and mentored the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products. Developed UPLC analytical methods for analyzing CSI products to assure quality meets product label claims.

Supported Outside Operations Manager and Global Procurement Manager with outside Tolling centers. Quality Control Laboratory Supervisor

PharMEDium Services LLC - Sugar Land, TX 06/2007 - 07/2013 Monitored product quality by conducting UPLC/MS and CE analytical testing in a compounding pharmacy. Responsible for hiring, training, coaching, scheduling, counseling, and disciplining employees. Worked in accordance with GLP, GDP, and GMP guidelines.

Kept equipment operating by certifying instrument performance; enforcing operating instructions; directing preventive maintenance; arranging for repairs; planning equipment replacement. Managed equipment operation by certifying instrument performance; enforcing operating instructions; directing preventive maintenance; arranging for repairs; planning equipment replacement. Developed Quality Reports (OOS, Data Trending, Lab Efficiency, and Departmental Project). Quality Control Associate Scientist

Introgen Therapeutics, Inc - Houston, TX 09/2005 - 12/2006 Performing analytical testing on cancer cells to assess the efficacy of tumor-suppressing drugs. Performed transfections and 96well plate ELISA tests. Tests performed include bioburden testing, plaque assay, cytopathic effect testing, restriction enzyme mapping, DNA extraction, UV Vis, HPLC, electrophoresis, and tissue culture manipulation and maintenance.

Quality Control Scientist

Wyeth Vaccines - Sanford, NC 01/2003 - 01/2005

Used LIMS to evaluate raw materials, intermediates and finished products to meet specifications. Tested in preparation for new product development, production, process improvement, stability and validation. Microbiology Lab Technician

FDA - Office of Regulatory Affairs - Jefferson, AR 09/2002 - 09/2003 Responsible for preparation of media and other analytical processes in compliance with national food safety regulations, writing SOP's, and independent initialization of start up procedures for new lab practices and lab organization for ISO accreditation.

Quality Control Analyst

Baxter Healthcare - Rochester, MI 01/2000 - 08/2002 Perform quantitative and qualitative analyses on a variety of plasma-based samples and raw materials. Performed routine gas chromatography assay, investigations after Out-of-Specification results by communicating with plant and lab personnel, and monthly reviews of assigned SOPs to determine if proper procedures were being followed.

EDUCATION

Bachelor's of Science: Animal Biology, Chemistry

Louisiana Tech University - Ruston, LA 1999

CERTIFICATIONS

CPGP License 704, Certified Pharmaceutical GMP Professional (ASQ Certified) August 2018 to December 2022

ACCOMPLISHMENTS

Developed and validated over 25 UPLC/Qda and HPLC/UV methods to reduce contract laboratory costs and lag time in product release.

Provided chromatography training for entry level chemists who later went on to develop LC methods and validation protocols.

Developed 3 analytical chemistry laboratories from startup to routine analysis. Received company award for enhancing the customer experience through improving quality processes and service commitments.



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