Shana Weathersby
Durham,NC
Summary
Accomplished Quality Specialist with extensive pharmaceutical industry experience(GLP, GMP, GxP) in chemistry, method validation, quality and regulatory documentation,data analysis, compliance, and clinical/commercial testing. Skilled in technical review,workflow management, and project coordination. Collaborative team player with strong communication skills and a commitment to meeting deadlines.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Specialist
IQVIA
07.2023 - 10.2025
- Review and approve GxP and GMP documentation to ensure compliance with IQVIA quality standards
- Identify and communicate data deviations to appropriate personnel
- Verify data accuracy, completeness, and regulatory compliance
- Reviewed production processes and identified potential quality issues.
- Reported problems and concerns to management.
Quality Assurance Specialist II
Cambrex
04.2022 - 04.2023
- Open and close Quality Events, including OOS, Deviations, CAPAs, and Change Controls
- Conduct final data reviews to ensure completeness and compliance with company SOPs, GMP, and GDP standard
- Prepare and review key documentation such as Certificates of Analysis (COAs), Stability Reports, and entries in TrackWise, LIMS (LabVantage), and BMRAM
- Support equipment qualification activities and LIMS builds
- Assist during audits by serving as a scribe or providing required documentation from the back room
- Recorded and organized test data for report generation and analysis.
- Reviewed production processes and identified potential quality issues.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
Laboratory Coordinator/Data Reviewer/Chemist 3
Guerbet
06.2020 - 04.2022
- Oversee daily operations across three Finished Goods Testing laboratories to ensure efficient workflow and on-time project delivery
- Plan and coordinate laboratory testing to meet client timelines and project priorities
- Manage sample receipt, storage, documentation, and chain of custody
- Collaborate with analysts to ensure samples are prepared and available for testing
- Conduct weekly sample management audits to verify compliance and accuracy
- Develop and execute weekly lab audit checklists covering quality, safety, and reagent management
- Verify proper sample storage, equipment maintenance, and PPE availability
- Ensure reagents and chemicals are within expiry and correctly stored
- Review and approve GxP/GMP documentation (data, reports, protocols, test methods, equipment records) in alignment with Guerbet Quality standards
- Identify and communicate data deviations; ensure accuracy, completeness, and regulatory compliance
- Responsible for review, and approval of GXP and GMP documentation while ensuring adherence to Guerbet’s Quality standards, guidelines, and values. Identify deviations in data, communicate those to appropriate individuals. Review data, making decisions regarding accuracy, completeness and adherence to compliance.
Performed data trending activities when appropriate. Communicate and collaborate with analyst to ensure proper quality and documentation of data. - Oversee daily operations across three Finished Goods Testing laboratories to ensure efficient workflow and on-time project delivery
Plan and coordinate laboratory testing to meet client timelines and project priorities
Manage sample receipt, storage, documentation, and chain of custody
Collaborate with analysts to ensure samples are prepared and available for testing
Conduct weekly sample management audits to verify compliance and accuracy
Develop and execute weekly lab audit checklists covering quality, safety, and reagent management
Verify proper sample storage, equipment maintenance, and PPE availability
Ensure reagents and chemicals are within expiry and correctly stored
Review and approve GxP/GMP documentation (data, reports, protocols, test methods, equipment records) in alignment with Guerbet Quality standards
Identify and communicate data deviations; ensure accuracy, completeness, and regulatory compliance
Technical Data Reviewer/Chemist 3
Aurobindo
01.2019 - 05.2020
- Ensured the integrity of the data generated in the QC lab, validations and R&D Analytical laboratories.
- Reviewed of all the testing performed by the analysts and associated documentation for accuracy and cGMP compliance in paper, ELN, and hybrid systems.
- Reviewed the laboratory instruments calibrations status logbook entries and column entries pertaining to notebooks to ensure accurate compliance.
- Reviewed software audit trails in the empower software, UV software and GC software assist in review of laboratory investigations, deviations.
- Performed data trending activities when appropriate.
- Communicated and collaborated with analyst to ensure proper quality and documentation of data.
- Communicated with analyst and others as appropriate of any deviations.
- Ensured the integrity of the data generated in the QC lab, validations and R&D Analytical laboratories.
Reviewed of all the testing performed by the analysts and associated documentation for accuracy and cGMP compliance in paper, ELN, and hybrid systems.
Reviewed the laboratory instruments calibrations status logbook entries and column entries pertaining to notebooks to ensure accurate compliance.
Reviewed software audit trails in the empower software, UV software and GC software assist in review of laboratory investigations, deviations.
Performed data trending activities when appropriate.
Communicated and collaborated with analyst to ensure proper quality and documentation of data.
Communicated with analyst and others as appropriate of any deviations.
Scientist, Gene Therapy
Pfizer, Eurofins (contractor)
10.2018 - 01.2019
- Bioburden, Elisa,and PCR testing
- Supported the design and implementation of a new GXP Gene Therapy lab at the Sanford, NC site. Reviewed and edited quality and EHS documentation.
- Supported Method Transfer and Validation with the execution of testing, documentation, data interpretation and communication of results to meet or exceed project timelines.
- Conducted weekly 5S audits and monthly safety audits.
Sr. Associate Scientist (Chemist)
Catalent
06.2017 - 08.2018
- Plan and execute laboratory work independently, utilizing customer milestones and business objectives.
- Create and maintain project schedules to meet client time frames and company SOPs.
- Author and/or review technical documents (protocols, SOPs, reports, COAs) for accuracy, thoroughness, and regulatory compliance.
- Review laboratory documentation and perform peer review/verification of transcription processes.
Scientist 1
Tergus Pharma
02.2017 - 06.2017
- Perform analytical testing using instrumentation and wet-chemistry techniques following methods and SOPs.
- Assist with method development and validation under direction of senior laboratory personnel.
- Train, coach, and mentor staff on technical issues, laboratory techniques, and assigned duties.
- Assemble data packs, enter and organize data in spreadsheets, and prepare timely reports
Bench Chemist-contractor
SRG Woolf (GSK)
08.2016 - 01.2017
- Execute laboratory methods, protocols, and specifications using HPLC, GC-MS, pH meters, and Karl Fischer titration.
- Prepare Empower reports and generate chromatography data using Empower 3 software.
- Support method development and validation tasks as assigned by senior staff.
- Ensure all work is completed within client-specified timeframes and company SOPs.
Chemist III-contractor
Planet Pharma (Merck)
11.2015 - 05.2016
- Tested incoming components using dimensional analysis and FTIR prior to production use.
- Applied ANSI testing standards and internal quality criteria to verify component acceptability.
- Managed strict deadlines, multitasked as production schedules changed, and adjusted testing priorities accordingly.
- Maintained documentation per SOPs and cGMP; reviewed documents for accuracy and completeness.
- Performed laboratory space audits for GMP adherence.
Lab Analyst-contractor
Spectraforce Technologies
04.2015 - 11.2015
- Ran assay and impurity testing using UPLC and HPLC; processed and reported results via Empower 2 and LIMS.
- Conducted stability testing support and performed chromatography plus auxiliary tests (pH, expelled volume, appearance).
- Followed cGLP/cGDP and SOPs; maintained regulatory documentation and performed timely cGMP reviews and lab audits.
Lab Analyst
Pace Analytical
05.2014 - 11.2014
- Tested water and soil for ammonia, nitrogen, phosphorus, and COD using Smartchem, Lachat, Sulfur Determinator, TOX, and Bomb Calorimeter.
- Performed additional methods as assigned by supervisors and recorded results per SOP.
Analytical Chemist
Metrics (Mayne Pharma)
06.2013 - 01.2014
- Gained experienced with stability methods, commercial products, and reference standards.
- Trained on and operated instruments including HPLC/UPLC, FTIR/ATR, dissolution apparatus, Karl Fischer titrator, UV/Vis, TGA, and DSC.
- Prepared and recorded data in notebooks; communicated results to clients promptly.
- Strong attention to detail, adherence to SOPs, and commitment to regulatory compliance (cGMP, cGLP, cGDP).
- Performed audits, document reviews, and quality assurance activities to ensure lab and documentation integrity.
Education
MS - Chemistry
Western Carolina University
Cullowhee12.2010
Pharmacy Technician Diploma - Pharmacy Tech
Penn Foster Career School
Scranton2010
Bachelor of Science -
Mars Hill
Mars Hill2007
Skills
- Data Review
- GLP
- GXP
- GMP
- Empower
- Customer Relationships
- Validation
- LIMS
- Stability
- Wet Chemistry
- HPLC
- Physical Properties Analysis
- Microscopy
- Spectroscopy
- Master Control Trackwise
- LIMS Labvantage
- BMRAM
- Smartsolve
- EMPOWER
- Smartsheets
- Sharepoint
Certification
Yellow belt-Six Sigma
COURSES
Yellow Belt, Six Sigma Certification
Timeline
Quality Specialist
IQVIA
07.2023 - 10.2025
Quality Assurance Specialist II
Cambrex
04.2022 - 04.2023
Laboratory Coordinator/Data Reviewer/Chemist 3
Guerbet
06.2020 - 04.2022
Technical Data Reviewer/Chemist 3
Aurobindo
01.2019 - 05.2020
Scientist, Gene Therapy
Pfizer, Eurofins (contractor)
10.2018 - 01.2019
Sr. Associate Scientist (Chemist)
Catalent
06.2017 - 08.2018
Scientist 1
Tergus Pharma
02.2017 - 06.2017
Bench Chemist-contractor
SRG Woolf (GSK)
08.2016 - 01.2017
Chemist III-contractor
Planet Pharma (Merck)
11.2015 - 05.2016
Lab Analyst-contractor
Spectraforce Technologies
04.2015 - 11.2015
Lab Analyst
Pace Analytical
05.2014 - 11.2014
Analytical Chemist
Metrics (Mayne Pharma)
06.2013 - 01.2014
Bachelor of Science -
Mars Hill
MS - Chemistry
Western Carolina University
Pharmacy Technician Diploma - Pharmacy Tech
Penn Foster Career School