Quality Assurance Wet Chemistry
Resume:
Vernes Terrell Scott
*************@******.***
PROFESSIONAL SUMMARY
In-depth knowledge of the global regulatory and quality requirements for the manufacture and testing of drug products.
•Over 10 years of Analytical Chemistry experience within the Pharmaceutical/food manufacturing industries.
•Extensive HPLC (Test method development and validation) with a GMP/cGMP environment.
•Exposure to various methods including but not limited to HPLC, GC, UV, UPLC, FTIR, ICP, Osmometer, pH and Karl Fisher.
•Exposure to analysis of extractable and leachable species in finished products.
•Extensive Wet Chemistry experience; USP, EP and some JP
•Excellent verbal, written and interpersonal communication skills.
EDUCATION
•Bachelor of Arts Interdisciplinary Natural Science, University of South Florida, Tampa, Florida
•Fulfilled course requirements for Bachelor of Arts, Southern Illinois University Carbondale, IL
Major Microbiology; Minor Chemistry and German
WORK EXPERIENCE
Nelson Laboratories, (Direct Hire) Itasca, IL 04/2023-01/2025
Chemist II
Performed analytical analysis of Sponsor’s Products by HPLC, UPLC, UV, FTIR, Karl Fisher and Wet Chemistry
Performed analytical testing according to client’s protocols, USP, EP and JP test methods
Authored Work Instructions, SOPs and STPs
Performed OQ for FTIR
Akorn Pharmaceuticals, (Direct Hire) Gurnee, IL 06/2020-02/2023
Quality Assurance Associate Contract Manufacturing Organization (CMO)
Reviewed and released finished products for Akorn distribution
Performed quarterly metrics from CMO clients
Reviewed and maintained stability testing data
Reviewed and approved final determination for Customer Complaints
Tracked and trend Change Controls, Deviations
Client: Akorn Pharmaceuticals, Lake Forest, IL
Kelly Services (Contractor), Oak Brook Terrace, IL 07/2019-01/2020
Senior Compliance Specialist
Reviewed audit findings and created holistic corrective/preventive actions with deliverables and effective check plans
Facilitated data or documentation corrections with analysts to ensure the ANDA Reports and related records were completed and appropriate references were made
Client: Stryker, Cary, IL
Real staffing (Contractor), Chicago, IL 10/2018-01/2019
Senior Quality Chemist
Authored new Test Method Validation procedures for Quality Control Chemistry Laboratory
Client: Abbott Laboratories, Lake Forest, IL
Datamatics Global Services (Contractor), Livonia, MI 03/2018-06/2018
Quality Assurance Specialist III
•Authored and revised Standard Operating Procedures
•Harmonized Test Methods
First Priority, Inc., (Direct Hire) Elgin, IL 08/2016-11/2017
Senior Chemist
Performed analytical analysis of In-Process and Finished Goods Products by HPLC, UV, Moisture Analyzer and Wet Chemistry. Wrote and revised Standard Operating Procedures and Test Methods, as per 21 CFR FDA
Performed analysis of extractable and leachable species in Finished Goods Products
Attended daily interdepartmental meeting and assigned daily activities for Finished Product group chemists
Participated in Out of Specification (OOS) investigations with CAPA measures
Maintained adherence to GMP/FDA standards and regulations
Responsible for test method development and validation
Participated in FDA Audits
Namaste Laboratories, (Direct Hire) Matteson, IL 06/2014-04/2016
Analytical Chemist/Quality Specialist
•Conducted external Quality Audits of Third Party Contract Manufacturers
•Performed analytical analysis of Finished Goods Products by Wet Chemistry
•Harmonized testing procedures and product specifications between Third Party Contract Manufacturers and Namaste Laboratories
•Wrote and revised Standard Operating Procedures, Test Method development and validation, Safety Procedures as per 21 CFR FDA
•Served as site Safety Lead
•Maintained adherence to GMP/FDA standards and regulations
•Responsible for test method development and validation
Glanbia Performance Nutrition (Formally Optimum Nutrition), (Direct Hire) Aurora, IL 02/2010-06/2014
Quality Assurance Analytical Chemist
•Performed Analytical and Chromatographic Methods of analysis by HPLC, UPLC, FTIR, and ICP to meet departmental objectives
•Audited Chemistry Laboratory according to good laboratory practices
•Wrote chemistry SOP’s, Test Method development and validation, updates and wrote new procedures to ensure compliance and accuracy to meet federal requirements
•Assisted in the formal training of laboratory chemists on topics such as cGMP, GLP, safety, and new employee training
•Reviewed and released documentation for raw materials, in- process samples, and finished products
•Managed laboratory operations in accordance with Part 21CFR FDA.
•Served two years as an active member with the Glanbia Safety Team
•Maintained adherence to GMP/FDA standards and regulations
•Responsible for test method development and validation
Aerotek Scientific (Contractor), Chicago, IL/ Schaumburg, IL 12/2008-02/2010
Client: H20 Plus
Quality Lab Analyst
•Developed and validated wet chemistry analytical testing
•Served as company correspondent in FDA audit
•Developed new documents and procedures to improve quality and increase efficiency
•Conducted weekly Quality Assurance meetings with department heads to address concerns affecting product quality, services, and procedures
•Maintained adherence to GMP/FDA standards and regulations
Client: King/Alpharma Pharmaceuticals
Quality Assurance
•Performed final review and release of analytical laboratory results
•Served as liaison between Management and Laboratory Personnel
•Reviewed ANADA changes for submission
•Maintained adherence to GMP/FDA standards and regulations
Vee Pak, (Direct Hire) Countryside, IL 07/2004-12/2008
Analytical Chemist
•Performed analytical testing of active and inactive constituents of finished products, raw materials, stability and in process samples
•Analytical testing includes: HPLC, GC, FTIR UV spectrophotometer and Wet Chemistry
•Wrote and revised Standard Operating Procedures and Work Instructions
•Restructured and managed stability program
•Performed final review of batch records, quality control inspector’s records, test methods and method transfers
•Performed IQ/OQ qualifications
•Conducted monthly department audits
•Trained personnel in documentation according to FDA guidelines
•Reviewed and responded to complaint investigation reports and corresponding Documents
•Maintained adherence to GMP/FDA standards and regulations
•Responsible for test method development and validation
•Participated in FDA Audits
•Responsible for test method development and validation, method transfer
Client: Abbott Laboratories, North Chicago, IL
Butler International (Contractor), Schaumburg, IL 08/2003-07/2004
Analytical Chemist
•Performed instrument qualification of HPLC and GC systems through linearity and precision- based studies
•Monitored all temperature control storage facilities of samples
•Analyzed stages 1-4 pharmaceuticals; Reviewed documentation for ANDA submission
•Training included method development and validation
•Short-term engagement included contractor at Abbott Laboratories
Morton Grove Pharmaceuticals, (Direct Hire) Morton Grove, IL 08/1995-10/2002
Quality Assurance Coordinator
•Managed and maintained quality assurance department according to FDA requirements
•Supervised daily activities of assistant technicians
•Led training seminars on quality standards, guidelines and applicable FDA regulations
•Performed final review and release of the following test records: raw materials, components, labels and inserts
•Served as an active participant in FDA audits
Quality Assurance Auditor
•Audited manufacturing of products and verified materials used were according to the product formulation
•Audited the filling of products into finished product and verified that the containers and closures were according to the requirements
•Determined whether package sizes met the USP Volume Delivery Requirements
Quality Control Chemist
•Performed chromatographic analysis of active and inactive constituents of health care pharmaceuticals using HPLC, GC, and Spectrophotometer instrumentation
•Characterized the physical properties of finished products
•Performed wet chemistry analysis of in-process and finished good
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