Quality Assurance Laboratory Operations

Vernes Terrell Scott

Wheaton, IL *****

Recruiter Note: Vernes Terrell Scott is a highly skilled Analytical Chemist with over 10 years of experience in laboratory environments, specializing in GMP/GLP laboratory practices, HPLC’s instrumentation, and quality assurance. He has extensive expertise in test method development, validation, calibration, and repair of lab instruments, including HPLCs, GC, FTIR, UPLC, and Karl Fischer. He has a strong background in laboratory maintenance, process instrumentation, and ensuring compliance with FDA regulations. His experience spans pharmaceutical, food, and contract manufacturing industries, where he has performed analytical testing, developed SOPs and maintained GMP compliance. He has worked on extractable and leachable analysis, stability testing, and quality audits while leading teams in calibration procedures and troubleshooting lab instrumentation. With a proven track record of managing laboratory operations, ensuring equipment maintenance, and implementing process improvements, Vernes is a valuable asset to any laboratory setting.

Summary:

Analytical Chemistry Expertise: Over 10 years of experience in analytical chemistry within the pharmaceutical and food manufacturing industries, specializing in test method development, validation, and laboratory operations.

Laboratory Instrumentation Proficiency: Extensive experience with HPLC, GC, FTIR, UPLC, ICP, and other lab instrumentation. Skilled in calibration, repair, and maintenance to ensure accurate and reliable results in a GMP-compliant environment.

GMP/GLP Compliance: In-depth knowledge of GMP/GLP laboratory practices, ensuring adherence to FDA, USP, EP, and JP standards for testing, documentation, and quality control.

Quality Assurance and Testing: Expertise in performing analytical testing, including extractable and leachable species analysis, stability testing, and wet chemistry analysis. Reviewed and released final results for raw materials, in-process samples, and finished products.

Process Instrumentation and Calibration: Proven experience managing process instrumentation and performing calibration procedures, ensuring compliance with laboratory standards and accurate testing protocols.

Test Method Development and SOPs: Skilled in test method development, creating and revising SOPs, Work Instructions, and Test Methods to improve laboratory efficiency and ensure regulatory compliance.

Troubleshooting and Technical Support: Hands-on experience in troubleshooting laboratory equipment and instrumentation, resolving issues related to calibration and maintenance to minimize downtime.

Regulatory Auditing and FDA Compliance: Experience participating in FDA audits, ensuring all testing and laboratory procedures meet regulatory requirements for quality and safety.

Leadership and Team Collaboration: Effective in mentoring and training laboratory staff on GMP, GLP, safety protocols, and best practices to maintain high standards of laboratory operations.

Extensive Industry Experience: Worked with major clients in the pharmaceutical industry, including Akorn Pharmaceuticals, Abbott Laboratories, and Stryker, demonstrating expertise in both GMP-compliant testing and laboratory operations.

Safety and Compliance: Strong commitment to maintaining a safe working environment, ensuring laboratory operations align with OSHA and FDA regulations, and upholding safety standards.

Collaborative Problem Solving: Adept at collaborating with cross-functional teams to address product quality concerns, and documentation discrepancies, and improve laboratory practices.

Analytical Testing for Product Quality: Conducted analysis on a wide range of products, ensuring the quality, stability, and compliance of raw materials and finished goods.

Skills:

Laboratory & GMP/GLP Practices: GMP/GLP laboratory practices, Regulatory compliance auditing, FDA safety standards, and Internal and external quality audits.

Test Method Development & Validation: Test method development, Test method validation, Test Method creation.

Calibration & Maintenance: Calibration and repair of lab instruments, Calibration procedures, Balance repair, Laboratory maintenance, Equipment qualification (IQ/OQ), and Instrumentation technician tasks.

Instrumentation & Analytical Techniques: HPLC instrumentation, UPLC, HPLC’s instrumentation, GC, UV, FTIR, ICP, Karl Fischer, Osmometer, pH analysis, Process instrumentation, Wet chemistry.

Quality Assurance & Control: SOP development, Work Instruction creation, Analytical result review and release, Batch record review, Stability testing, Extractable and leachable analysis.

Regulatory & Compliance: SOP development, Regulatory compliance, FDA audits, Review of ANDA changes for submission, Analytical result release.

Cross-Functional Collaboration: Cross-functional collaboration, Interpersonal and communication skills, Training and mentoring laboratory personnel.

Corrective Actions & Process Improvement: CAPA investigations and corrective actions, Troubleshooting and process improvements.

Safety & Standards Compliance: OSHA and FDA safety standards, Harmonizing test methods, Training seminars on quality standards, guidelines, and applicable FDA regulations.

Professional Experience:

Nelson Laboratories, Itasca, IL Mar 2023 - Jan 2025

Chemist II

Conducted comprehensive analytical analysis of Sponsor’s Products using HPLC, UPLC, UV, FTIR, Karl Fischer titration, and Wet Chemistry.

Performed analytical testing according to clients' protocols, USP, EP, and JP test methods.

Authored and revised Work Instructions, SOPs, and STPs to ensure accuracy and compliance with regulatory standards.

Performed Operational Qualification (OQ) for FTIR instruments.

Ensured adherence to GMP standards in all laboratory processes and maintained laboratory instrumentation.

Conducted routine calibration and maintenance of laboratory equipment to ensure accurate and reliable results.

Participated in method development and validation for new analytical procedures.

Akorn Pharmaceuticals, Itasca, IL Jun 2020 - Feb 2023

Quality Assurance Associate Contract Manufacturing Organization (CMO)

Reviewed and released finished products for distribution, ensuring compliance with quality standards.

Performed quarterly metrics analysis from CMO clients to monitor performance and adherence to specifications.

Reviewed and maintained stability testing data, ensuring proper documentation and accuracy.

Reviewed and approved final determinations for customer complaints, implementing corrective actions as necessary.

Tracked and trended Change Controls and Deviations to identify areas for improvement and ensure regulatory compliance.

Maintained GMP standards in laboratory practices, ensuring equipment calibration and repair were performed regularly.

Conducted regular audits of CMO facilities to ensure compliance with regulatory standards.

Assisted in the development and implementation of quality improvement initiatives.

Akorn Pharmaceuticals, Gurnee, IL Jul 2019 - Jan 2020

Senior Compliance Specialist

Upgraded Domain Controllers, maintained Group Policy Objects (GPOs), and hosted Red Hat Linux servers.

Reviewed audit findings and created holistic corrective/preventive actions with deliverables and effective check plans.

Facilitated data or documentation corrections with analysts to ensure ANDA Reports and related records were completed and appropriately referenced.

Ensured adherence to GLP and GMP standards in all compliance activities and laboratory operations.

Oversaw laboratory instrumentation maintenance, calibration, and repair.

Conducted risk assessments to identify potential compliance issues and implement preventive measures.

Developed and delivered training programs on compliance and regulatory requirements for staff.

Stryker, Cary, IL Oct 2018 - Jan 2019

Senior Quality Chemist

Authored new Test Method Validation procedures for the Quality Control Chemistry Laboratory.

Ensured adherence to GMP and GLP standards in all testing and validation processes.

Maintained laboratory instrumentation and performed calibration and repair as needed.

Participated in laboratory audits and implemented corrective actions to address audit findings.

Collaborated with cross-functional teams to develop and optimize analytical methods.

Conducted root cause analysis for laboratory deviations and implemented corrective actions.

Abbott Laboratories Mar 2018 - Jun 2018

Quality Assurance Specialist III

Authored and revised Standard Operating Procedures to ensure compliance with regulatory standards.

Harmonized Test Methods across different laboratory processes to maintain consistency and accuracy.

Ensured adherence to GMP and GLP standards in all quality assurance activities.

Maintained and calibrated laboratory instrumentation, ensuring accurate and reliable results.

Conducted internal audits to ensure compliance with quality management systems.

Assisted in the preparation and submission of regulatory documents for product approvals.

First Priority, Inc., Elgin, IL Sep 2016 - Nov 2017

Senior Chemist

Performed analytical analysis of In-Process and Finished Goods Products using HPLC, UV, Moisture Analyzer, and Wet Chemistry.

Wrote and revised Standard Operating Procedures and Test Methods in compliance with 21 CFR FDA regulations.

Conducted analysis of extractable and leachable species in Finished Goods Products.

Attended daily interdepartmental meetings and assigned daily activities for Finished Product group chemists.

Participated in Out of Specification (OOS) investigations and implemented CAPA measures.

Maintained adherence to GMP standards and regulations in all laboratory processes.

Responsible for test method development and validation, as well as participating in FDA Audits.

Managed laboratory instrumentation, including calibration and repair.

Conducted stability studies to ensure product quality over time.

Developed and implemented quality control procedures to improve laboratory efficiency.

Namaste Laboratories, Matteson, IL Jun 2014 – Apr 2016

Analytical Chemist/Quality Specialist

Conducted external Quality Audits of Third Party Contract Manufacturers to ensure adherence to GMP standards.

Performed analytical analysis of Finished Goods Products using Wet Chemistry techniques.

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, and Safety Procedures as per 21 CFR FDA regulations.

Served as site Safety Lead, ensuring compliance with safety standards and procedures.

Maintained adherence to GMP and GLP standards in all laboratory processes.

Responsible for test method development and validation, as well as calibration and repair of laboratory instrumentation.

Conducted method transfer and validation for new analytical methods.

Provided technical support and guidance to contract manufacturers.

Education & Certification:

Bachelor of Arts, University of South Florida, Tampa, Florida

Major Microbiology: Minor Chemistry and German

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