Shana Weathersby
Durham,US
Summary
Quality Control Specialist with 10+years of pharmaceutical quality experience overseeing GxP/GMP documentation, technical reviews, and laboratory operations. Demonstrates expertise in method validation, data trending, CAPA/OOS management, and LIMS-related records to ensure data integrity and regulatory compliance. Focused on streamlining processes, improving documentation accuracy, and supporting cross-functional teams to drive reliable, compliant testing and continuous quality improvements.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Quality Control Specialist 1
Iqvia
07.2023 - 11.2025
- Responsible for review, and approval of GXP and GMP documentation (Laboratory Data: electronic and paper; test records, protocols, reports, test methods, equipment records) while ensuring adherence to company Quality standards, guidelines, and values.
- Identify deviations in data, communicate deviation to appropriate individuals.
- Review data, making decisions regarding accuracy, completeness, and adherence to compliance.
- Performed data trending activities when appropriate.
- Communicate and collaborate with analysts to ensure proper quality and documentation of data. Fostered effective communication with analysts to enhance documentation accuracy, resulting in improved team efficiency and streamlined quality processes.
Quality Assurance Specialist II
Cambrex
04.2022 - 04.2023
- Open and close Quality Events such as OOS, Deviations, CAPAs, Change Controls.
- Final review of data for completeness and making sure it follows company SOPs, and that it is GMP, GDP compliant. Examples include but not limited to: COAs, Stability Reports, Equipment qualifications, LIMS builds.
- Assist with Batch record Review
- Assist with Audits by either scribing or working in the back room providing documentation when necessary.
Laboratory Coordinator
Guerbet
11.2021 - 04.2022
- Ensure smooth and consistent flow of three laboratories within the Finished goods Testing Side.
- Plan and coordinate laboratory testing to ensure the most recent project and client timelines are met.
- Sample receipt to ensure proper chain of custody including proper storage and documentation.
- Coordinate with analysts to ensure samples are available and ready for testing as necessary.
- Conduct weekly sample management audits.
- Created and maintained a visual board to communicate current project status at a glance.
- Communicates current and upcoming testing, roadblocks and paths forward.
- Communicates across departments and levels.
- Ensures lab efficiencies and transparency at all times.
Data Reviewer
Guerbet
12.2020 - 04.2022
- Responsible for review, and approval of GXP and GMP documentation (Laboratory Data: electronic and paper; test records, protocols, reports, test methods, equipment records) while ensuring adherence to Guerbet’s Quality standards, guidelines, and values.
- Identify deviations in data, communicate deviation to appropriate individuals.
- Review data, making decisions regarding accuracy, completeness, and adherence to compliance.
- Performed data trending activities when appropriate.
- Communicate and collaborate with analysts to ensure proper quality and documentation of data.
Quality Tech III
Guerbet
06.2020 - 02.2022
- Performs testing in support of clinical and commercial products, raw materials and validation samples. Analyze and interpret results, making decisions regarding the accuracy, completeness and adherence to compliance. Role currently performed as needed to ensure consistent flow of laboratory/manufacturing.
Chemist B/Technical Reviewer
Aurobindo
01.2019 - 05.2020
- Performed KF and HPLC analyses to validate inhaler solubility and stability with documented results.
- Prepared and tested metered dose inhaler samples to meet research and commercial protocols.
- Trained junior analysts on lab workflows and cGMP documentation to boost team capability.
- Reviewed test data, instrument logs, and software audit trails to ensure regulatory compliance and data integrity.
- Technical Review
- 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’ calibration 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 the review of laboratory investigations, deviations.
- Performed data trending activities when appropriate.
- Communicated and collaborated with the analyst to ensure proper quality and documentation of data.
- Communicated with the analyst and others as appropriate about any deviations.
Scientist
Pfizer (Eurofins)
10.2018 - 01.2019
- Implemented bioburden, ELISA, and PCR testing workflows to support method transfer and validation efforts.
- Supported GxP gene therapy lab setup by editing quality and EHS documentation to meet compliance timelines.
- Executed method transfer testing and data interpretation to deliver results within project deadlines.
- Conducted weekly 5S and monthly safety audits to improve laboratory organization and reduce hazards.
- Conducted experiments to analyze drug efficacy, resulting in measurable improvements in formulation stability and performance.
Sr. Associate Chemist
Catalent (Aerotek)
06.2017 - 08.2018
- Executed laboratory protocols independently to meet client milestones and regulatory expectations.
- Maintained project schedules to align with client timelines and company SOPs, improving on-time delivery.
- Authored and reviewed technical documents for accuracy and regulatory compliance across studies.
- Performed peer review of laboratory records to ensure transcription accuracy and data integrity.
- Conducted rigorous quality control tests on pharmaceutical products, ensuring compliance with industry standards and enhancing product reliability.
Scientist 1
Tergus Pharma
02.2017 - 06.2017
- Performed analytical testing using chromatography and wet-chemistry methods ensuring timely release of results.
- Assisted in method development and validation under senior guidance, producing reproducible assay protocols.
- Trained and mentored laboratory staff on techniques and SOPs, improving team testing consistency.
- Organized and entered experimental data into spreadsheets and assembled data packs for regulatory review.
- Conducted experiments to analyze drug efficacy, leading to actionable insights that informed product development strategies.
Bench Chemist
GSK (SRG Woolf)
08.2016 - 01.2017
- Executed HPLC and GC-MS analyses according to SOPs, meeting client deadlines consistently.
- Generated Empower 3 chromatography reports that improved data traceability and review efficiency.
- Supported method development and validation tasks that produced measurable improvements in assay reliability.
- Performed Karl Fischer titrations and pH measurements ensuring compliance with specifications and reducing rework.
- Collaborated with team members to enhance laboratory efficiency, fostering a cohesive work environment and improving project timelines.
Chemist 3
Planet Pharma (Merck)
11.2015 - 05.2016
- Performed dimensional analysis and FTIR testing to verify incoming components before production, ensuring compliance with specifications.
- Applied ANSI testing standards and internal criteria to accept or reject components, reducing nonconformances and rework.
- Maintained GMP-compliant documentation and reviewed SOP records for accuracy to support batch release decisions.
- Prioritized testing tasks under shifting production schedules to meet strict deadlines and sustain on-time manufacturing.
- Audited laboratory spaces for GMP adherence and implemented corrective actions that improved inspection readiness and process control.
- Conducted complex chemical analyses, delivering precise results that enhanced product quality and minimized rework.
Laboratory Analyst
BD (Spectraforce Technologies)
04.2015 - 11.2015
- Executed UPLC and HPLC assays and reported results via Empower 2 and LIMS, ensuring timely data availability.
- Performed stability testing and chromatography with auxiliary tests, producing reliable batch release data.
- Maintained cGLP/cGDP and SOP compliance and completed cGMP reviews and lab audits to uphold regulatory standards.
- Improved documentation accuracy and traceability, resulting in a measurable reduction in review revisions.
- Conducted quality control tests, ensuring compliance with industry standards and resulting in zero product recalls during tenure.
Laboratory Analyst
Pace Analytical
05.2014 - 11.2015
- Conducted analytical testing of water and soil samples using Smartchem, Lachat, and TOX to ensure regulatory compliance.
- Validated assay results against SOPs and corrected procedural deviations to improve data reliability.
- Reduced sample turnaround by optimizing instrument run sequences, producing measurable results in reporting time.
- Trained lab staff on sulfur determination and bomb calorimeter operation to increase testing coverage and consistency.
- Executed precise laboratory tests on samples, ensuring compliance with EPA safety standards and enhancing overall data integrity.
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
Cullowhee, NCBS - Chemistry
Mars Hill College
Mars Hill, NCPharmacy Technician Diploma - undefined
Penn Foster Career School
Scranton, PASkills
- GMP Experienced
- GLP Experienced
- GXP Experienced
- Quality Assurance Skillful
- Data Analysis Skillful
- Laboratory Management Skillful
- Compliance Skillful
- Method Validation Skillful
- Technical Review Experienced
- Documentation Experienced
- Quality Control Experienced
- Chemistry Experienced
- Laboratory Testing Experienced
- Data Trending Skillful
- Project Management Beginner
Accomplishments
Publication
SCIENCEDIRECT , 2018
Thesis: (2+2) Dimerization of CinnamylideneMalonic Acid
Certification
Yellow Belt -Six sigma
Hobbies
I love gardening, journaling, scrapbooking, do-it-yourself projects, passionate about animals and animal care, animal rights, and human rights
Additional information
- Publication
- SCIENCEDIRECT, 2018
- Thesis: (2+2) Dimerization of CinnamylideneMalonic Acid
Languages
English
Full Professional
Timeline
Quality Control Specialist 1
Iqvia
07.2023 - 11.2025
Quality Assurance Specialist II
Cambrex
04.2022 - 04.2023
Laboratory Coordinator
Guerbet
11.2021 - 04.2022
Data Reviewer
Guerbet
12.2020 - 04.2022
Quality Tech III
Guerbet
06.2020 - 02.2022
Chemist B/Technical Reviewer
Aurobindo
01.2019 - 05.2020
Scientist
Pfizer (Eurofins)
10.2018 - 01.2019
Sr. Associate Chemist
Catalent (Aerotek)
06.2017 - 08.2018
Scientist 1
Tergus Pharma
02.2017 - 06.2017
Bench Chemist
GSK (SRG Woolf)
08.2016 - 01.2017
Chemist 3
Planet Pharma (Merck)
11.2015 - 05.2016
Laboratory Analyst
BD (Spectraforce Technologies)
04.2015 - 11.2015
Laboratory Analyst
Pace Analytical
05.2014 - 11.2015
Analytical Chemist
Metrics (Mayne Pharma)
06.2013 - 01.2014
BS - Chemistry
Mars Hill College
Pharmacy Technician Diploma - undefined
Penn Foster Career School
MS - Chemistry
Western Carolina University