Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Yaniec Webster

Raleigh

Summary

Highly ambitious and accomplished QC Technical Reviewer with a proven track record in regulatory compliance and data accuracy. Qualified in HPLC and LIMS, I excel in problem-solving and effective communication, consistently meeting and exceeding goals while ensuring quality control in cGMP environments. My attention to detail drives successful outcomes in the data review processes.

Overview

22
22
years of professional experience

Work History

QC Technical Reviewer

Pfizer
Rocky Mount
02.2023 - 08.2025
  • Reviewed data for a variety of testing (HPLC/UPLC, GC, ICP-MS, Atomic Absorption (Flame and Graphite), Karl Fischer, Total Organic Carbon, UV/Vis, FTIR, Osmometer, BYK colorimeter, IL Flame Photometer, Polarimeter, Thin Layer Chromatography) for accuracy, compliance, and completeness according to regulatory standards and historical trends.
  • Assessed the quality of data in accordance with applicable regulations and standards, using a variety of software (LIMS, Empower, Nugenesis, PLOG).
  • Reviewed equipment logbooks for compliance/audit purposes.
  • Worked successfully with a diverse group of coworkers to accomplish goals and address issues related to the products.

Quality Assurance Specialist (Data Review)

Recipharm
Morrisville
09.2021 - 02.2023
  • Performed cGMP peer review of data (HPLC, wet chemistry, physical tests) per client methods/protocols/USP for Stability, Finished Product, In Process, and investigational studies.
  • Received/signed for incoming materials/shipments. Performed sample management (sample labeling and inventory).
  • Trained new and incoming Quality Assurance Specialists.
  • Reviewed Certificate of Analysis and ISR’s.
  • Proficient in using several types of software/instruments (Microsoft Teams, Lab Solutions, Open Lab, FTIR, Empower, Total Chrome, Malvern, Proveris, LIMS, eSystems, PharmSpec, VLOG, CITDAS, Tiamo, ViewLinc, Sharepoint, LC-MS, GC, HPLC/UPLC, Work Front, and Changepoint).
  • Proficient in instrument qualification (IQ/OQ/PQ), and calibration of instruments (Pipettes, Vaisala Loggers).

Data Reviewer (Contract)

Guerbet
Raleigh
03.2021 - 09.2021
  • Multitasked in the review of wet chemistry, raw materials, Stability, and Finished Product testing per GxP requirements and test methods with accuracy and precision.
  • Reviewed Osmolality, HPLC Assays/Impurities (Total Chrome), Titrations (Karl Fischer, Coulometer, and manual), UV/Vis, TLC, Polarimeter, and LIMS per USP, SOP’s, and test methods.
  • Identified deviations, out of specifications, and out of trend data.
  • Created/revised templates for analyst/laboratory documentation to reduce deviations and out of specifications.
  • Reviewed equipment logbooks for compliance/audit purposes.
  • Used teamwork and communication with analysts and management to ensure data quality per GxP and ALCOA principles along with supporting internal/external customer requirements/deadlines.

Data Reviewer

Aurolife Pharma
Durham
05.2019 - 03.2021
  • Reviewed data for cGMP, method validations, method transfers and non cGMP data (HPLC, UPLC, viscosity, Karl Fischer, Osmolality, Particulate Matter, HIAC, UV/Vis) per client methods, SOP’s, USP, JP, and BP.
  • Reviewed/edited protocols and methods (validations, method transfers) for cGMP and non cGMP projects, created and populated Certificate of Analysis, created and reviewed Trend Reports.
  • Tracked experimental results, coordinated data reviews, and produced detailed reports.
  • Trained new incoming Data Reviewers,
  • Compiled regulatory folders (for FDA purposes).

Data Reviewer (Senior Associate Scientist)

Catalent
Morrisville
10.2018 - 12.2018
  • Reviewed Trend Reports and Certificate of Analysis.
  • Reviewed cGMP data including HPLC (Assay/Impurities), Identification tests, pH, Titrations (Karl Fischer, Coulometer, and manual), UV/Vis, and Dissolution according to USP, EP, Standard Test Methods, and SOP’s.

QC Technical Reviewer

Pfizer
Rocky Mount
02.2018 - 09.2018
  • Reviewed cGMP data including Titrations (Karl Fischer, Coulometer, and manual), HPLC (Assay/Impurities), Identification tests, pH, Polarimeter, UV/Vis, IL Flame Photometer, and FTIR according to USP and Standard Test Methods.
  • Compiled/organized records for TSR’s (Technical Service Request).
  • Proficient with Empower, NuGenesis, Electronic Data Review, and LIMS.

Data Reviewer

KBI
Durham
09.2016 - 02.2018
  • Reviewed cGMP and non cGMP data (HPLC, ELISA, CE, SDS, and Mass Spectrometry) according to client methods.
  • Reviewed/verified documentation (calculations and documented information) for accuracy, completeness, and cGMP compliance.
  • Reviewed method development, method validations, Certificate of Analysis, and method revisions.
  • Wrote and developed Protocols and Analytical Test Methods.
  • Proficient with ATLAS and EMPOWER.

Data Review Specialist/Lab Analyst

Eurofins
Lancaster
09.2014 - 09.2016
  • Performed chemistry testing and reviewed data (Dissolution, routine testing, non-routine testing, HPLC, wet chemistry) in accordance with applicable SOP’s, client methods, USP, BP, and EP.
  • Tested and reviewed chemistry sample test data (Karl Fischer, particle size, osmolality, TLC), method development data, method feasibility, and trend reports according to cGMP and GLP practices.
  • Reviewed data for Stability, Release, Finished Products, and Raw Materials.
  • Proficient with ATLAS, LIMS, SLIM, and electronic notebooks.

Civil Affairs Specialist

United States Army Reserve
Sumter
11.2003 - 11.2015
  • Identified critical requirements needed by local citizens in combat or crisis situations.
  • Researched, coordinated, conducted and participated in the planning and production of civil affairs related documents, while enabling the civil-military operations of the supported commander.
  • Helped plan U.S. government interagency procedures for national or regional emergencies, assisted with civil-military planning and support, coordinated military resources to support reconstitution or reconstruction activities.
  • Participated in two tours to Iraq (2006-2007 and 2009-2010). Conducted briefings, collected data, wrote detailed reports, and interacted with a diverse population.

Lab Analyst

DSM Pharmaceuticals
Greenville
08.2012 - 04.2014
  • Tested a variety of drug samples according to client methods, USP, and SOP’s in compliance with cGMP and GLP practices.
  • Multitasked and handled multiple samples at once (Stability, Release, Raw Materials).
  • Proficient in a laboratory setting (HPLC, Gas Chromatography, Karl Fischer, pH, Spectroscopy, TLC, Assay, Related Subs, Content Uniformity, Manual Titrations, Dissolution, UV/Vis).
  • Proficient at troubleshooting, ATLAS, LIMS, and SLIM systems.

Education

Bachelor of Arts - Chemistry/Math

East Carolina University
Greenville, NC
05-2012

Skills

  • Data review
  • Regulatory compliance
  • Quality control
  • Laboratory software
  • cGMP practices
  • Time management
  • Problem solving
  • Effective communication
  • Microsoft Office
  • Works well with others
  • Meets and exceeds goals
  • Flexible and reliable
  • Attention to detail
  • Diverse

Accomplishments

  • Received recognition several times for going above and beyond, taking on extra workloads, meeting goals, and helping others (Pfizer)
  • Received Impact Awards for client satisfaction (Eurofins Lancaster Laboratories)
  • Received Inspire Awards for going above and beyond and helping to meet the monthly budget (Eurofins Lancaster Laboratories)
  • Received several awards and a Hero of the Week award (Army Reserves) for going above and beyond on deployments to help meet goals
  • Received recognition twice at Recipharm for successful audits

Timeline

QC Technical Reviewer

Pfizer
02.2023 - 08.2025

Quality Assurance Specialist (Data Review)

Recipharm
09.2021 - 02.2023

Data Reviewer (Contract)

Guerbet
03.2021 - 09.2021

Data Reviewer

Aurolife Pharma
05.2019 - 03.2021

Data Reviewer (Senior Associate Scientist)

Catalent
10.2018 - 12.2018

QC Technical Reviewer

Pfizer
02.2018 - 09.2018

Data Reviewer

KBI
09.2016 - 02.2018

Data Review Specialist/Lab Analyst

Eurofins
09.2014 - 09.2016

Lab Analyst

DSM Pharmaceuticals
08.2012 - 04.2014

Civil Affairs Specialist

United States Army Reserve
11.2003 - 11.2015

Bachelor of Arts - Chemistry/Math

East Carolina University

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Yaniec Webster