Sara H.

Experience

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  Private Tutor

  Jan 2008 - Jan 2009

  Tutor

  Chemistry, Calculus, Biology, Biochemistry, Reading

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  ImmunoReagents, Inc.

  Jan 2010 - Apr 2011

  Lab Tech.

  *Performed quality control (SDS PAGE, IEP) experiments to test product integrity*Prepared buffer solutions for production and testing*Tested for stability of products in inventory*Maintained lab equipment via monthly calibrations

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  North Carolina State University

  Jan 2010 - Aug 2010

  Independent Student Research

  Explored the role of Tat-SF1 in HIV-1 RNA Stability through the use of transfected viral plasmids into HeLa cells that stably express a short hairpin RNA. Employed Northern and Western blotting to understand stability of RNA and amount of protein. Ran in vitro transcription reaction to develop HIV-1 RNA specific probe.Harvested RNA and DNA.Employed the use of a non-radioactive DIG labeling system for detection.

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  NCSU

  Jul 2010 - Jan 2011

  · Isolation of thrombin through the use of a binding aptamer.· Development of protocols and maintenance of records.· Developed buffer for protein dialysis.· Used fluorescence to determine protein:aptamer binding to understand active site of protein. · Third semester serving as teaching assistant for an introductory biochemistry course intended for science and engineering majors.· Teach a problem session once weekly.· Prepare lesson plans and work with students to understand material.· Hold office hours as needed.

  • Independent Student Research

    Aug 2010 - Jan 2011

  • Biochemistry Teaching Assistant

    Jul 2010 - Jan 2011
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  KBI Biopharma

  Aug 2011 - Jan 2012

  Research Associate (Contractor)

  Applied biophysical, biochemical and biopharmaceutical principles and techniques to develop protein formulations. Conducted and monitored stability studies of proteins and monoclonal antibodies. Worked with various bio-analytical techniques applicable to monitor physical and chemical stability of proteins. Preformed protein characterization using various techniques and troubleshooting independently.Interacted with internal and external collaborators.

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  Novartis

  Sept 2012 - Jan 2013

  QC Analyst I (Contractor)

  GMP Testing support for Biochemistry assays (SDS-PAGE, DNA Threshold, SRD, UV/Vis Spectrometry, NA Presence, Trypsin Activity)Responsible for testing of in-process samples from manufacturing with quick turn around timesBrought in new equipment into the lab, scheduled qualifications and managed preventative maintenanceParticipated in control qualificationStability testing of samplesCollaborated with colleague to introduce new consumable ordering system within lab to support lean lab initiatives. Visa mindre

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  Argos Therapeutics, Inc. (NASDAQ: ARGS)

  Jan 2013 - Sept 2015

  QC Analyst I

  Responsible for conducting routine and non-routine analysis of raw materials, in process, and finished formulations according to standard test methods. Test methods include gel electrophoresis, spectrophotometry, immunophenotyping, and Northern blot analysis.Worked to streamline sample management program, specifically that of RNA samples within QC.Authored sample management SOP and collaborated to update and revise current SOPs and STMs within QCCompiles data for technical reports.Read and analyzed EM plates for type and count of organismsShipping of samples and EM plates for further analysis Participated in method validationInterfaced with QA and Manufacturing to improve final vial inspection procedures to ensure consistency and efficacy of inspections. Authored Laboratory Investigation Reports and worked to minimize and prevent deviations during testing. Visa mindre

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  Argos Therapeutics

  Jan 2015 - Apr 2017

  Quality Assurance Specialist

  • QA review of GMP documentation, including Item Specifications, SOPs, production records, test methods and validation protocols and reports. • Initiated and closed deviations, CAPAs, change requests and non-conforming reports• Reviewed executed batch records and participate in the disposition of Clinical Trials Materials, including review of all associated documentation • Provided QA review and oversight for product shipments• Reviewed and approved QC worksheets and results• Worked to improve communication and close gaps between QC and QA • Reviewed QC stability testing, stability protocol amendments and summary reports• Managed personal workflow and maintained project deadlines• Provided compliance oversight and timely review and approval of documentation supporting method qualification/validation• Provided information as needed to support BLA preparation • Performed QA release of products to meet timelines for patient dosing • Implemented a structure of QA review that maintains consistency • Provided timely review of QC testing through timelines agreed upon by QC and QA• Provided communication between QA and QC of timelines of batch release • Stability protocol, data and summary report review and approval • Working knowledge of quality system elements and cGMP regulations• Provided training, document creation, communication and oversight to meet established quality goals. • Duties and responsibilities carried out with limited supervision. Visa mindre

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  BioAgilytix

  Jan 2017 - Jun 2019

  QA Auditor
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  Tergus Pharma

  Apr 2017 - Jan 2017

  Sr. QA Specialist
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  CoIummne

  Jun 2019 - Dec 2021

  QA Specialist III
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  CoIMMUNE, Inc.

  Jan 2022 - Mar 2024

  Sr. Quality Assurance Supervisor
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  Pfizer

  Mar 2024 - now

  Quality Assurance Manager - Site Data Integrity Lead