Quality Assurance Team Member

Larisa M. Kubit

Shrewsbury, MA ***** 508-***-**** *******@*****.***

CAREER PROFILE

Detail-oriented, highly motivated, experienced candidate with a strong analytical chemistry background is looking for a Quality Control/Quality Assurance Associate, Compliance Specialist, Data Reviewer, or a similar position on a project team. Experienced with analytical instrumentation including chromatography HPLC, UV-Vis, FTIR, MS, ELISA, LC/MS, TGA, DSC, NMR, GC, UPLC, pH, VNA, conductivity, weight scale, turbidity, as well as viscometer and moisture analyzer for qualitative and quantitative analysis of carbohydrate products and proteins. Possess solid documentation skills and familiarity with GMP, GLP, SOP, LIMS, GDP, Deviations, Incident Reports, CAPA, Change Control, Out of Specifications, Trackwise, Empower, Chemstation, Smart Lab, Adobe, Maximo and Analyst. Calibration and maintenance of instrumentation experience was gained working at all the positions listed below. Working knowledge of pertinent standards and guidance documents ISO9001, ISO13485, ISO 10993, 21 CFR 58, and FDA Guidance Documents for biocompatibility. A laboratory audit is an assessment performed to demonstrate that the laboratory’s operations are according to regulatory standards and accreditation regulations. An enthusiastic, energetic candidate with a strong work ethic and excellent attendance to detail who works well independently or as part of a team.

CAREER HIGHLIGHTS

Dupont Inc., Marlborough, MA April 2024 – November 2024 (Contract)

R&D Associate-Analytical Chemist

Working with lead scientists to design and execute experiments, and based on findings, provide feedback and recommendations for test method improvements and modifications.

Independently conducting product work-up/analysis/characterization, and experimental documentation using an electronic laboratory notebook system.

Preparing and analyzing small molecules and polymer samples through spectroscopic methods (including NMR, FT-IR, GPC, etc) Operation and maintenance of laboratory instrumentation, including FT-IR, NMR, GPC, TGA, DSC, DMA, GC, UPLC. Characterization of raw materials and products Accurate documentation of experimental details and test results in a timely manner.

Prepare paperwork for sample shipping and analytical work request.

Mechanical tests are on Instron and VNA.

Astellas Inc., Westborough, MA January 2022 – May 2023 (Permanent)

Sr. QC Associate

Provided QC testing on process and final products experiencing parenteral testing, cell culture, analytical method validation, RT-qPCR, Immunofluorescence, Flow Cytometry and/or cell-based assays. Approved testing in GMP Complaint Laboratory. Maintained, calibrated, and operated equipment and instruments supporting cell bioassays.

Tracked and tested products according to stability protocols. Managed Instrument Validation for QC equipment. Developed, revised, and reviewed SOP’s, qualification/validation protocols and reports.

I interacted with agents from Regulatory agencies and participated in Pre-Approval Inspections. Completed routine records review of test data and related documents, lab audits.

Conducted investigations regarding out-of-specifications results. Implemented continuous improvements in the GMP QC systems to ensure compliance with documented policies. Reviewed proposed changes to systems, procedures, methods, and submissions to regulatory agencies.

Astellas Inc., Westborough, MA August 2021 – January 2022 (Contract)

QC Review Resource

Ensured research studies were conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal procedures, domestic and Japanese regulatory guidelines and standards.

Conducted quality assurance and quality control review, including verification of data against approved supporting documentation/sources of medical/scientific information for aggregate reports.

Performed data integrity reviews of Development and Research data and reports intended for regulatory filings. Recommend changes to QA/QC findings.

Recorded QA/QC metrics per defined categories. Ensured integrity, accuracy and consistency of data and documents.

Sanofi Inc., Framingham, MA November 2020 – August 2021 (Permanent)

Compliance Specialist

Provided Gemba Support.

Performed batch record review as well as review of column packing and qualification records. Functioned as SME on input related to quality decisions.

Approved non-conforming material discards. Performed logbook review.

Provided support to the floor support to the operations department.

Issued action notices and conducted affiliated provisional release.

Conducted logbook audits against compliance requirements.

Reviewed cleaning verification related documentation against specification.

Performed media/buffer and intermediate release.

Prepared Bioreactor summary.

Supported internal audit preparation activities and conducted walkthrough inspections.

Executed containment activities.

Provided off-hour support for batch records and logbook issuance, lab audits.

Partnered with manufacturing and supported operations to ensure a culture of continuous compliance.

Provided training to new employees, Revised procedures/SOPs. Initiated and investigated QA review deviations, Performed Bulk Gas release. Reviewed non-routine sample requests.

Sanofi Inc., Framingham, MA January 2020 – October 2020 (Contract)

QC Analyst II

Performed analytical testing on intermediate, in-process and final product materials using a variety of equipment to include GC, FTIR, UV-Vis, and physical property instrumentation.

Authored technical reports. Trained on all documents assigned to training plan and completed training as assigned.

Received, verified and logged incoming samples.

Performed or participated in equipment qualifications.

Performed or participated in method validations.

Participated in audits.

Conducted safety and weekly compliance walkthroughs. Responsible for adherence to policies, procedures, and SOPs. Participated in lab investigations.

Charles River Labs Inc., Shrewsbury, MA April 2017 – October 2018 (Permanent)

Research Assistant II

Adhere to sterile practices for handling immunocompromised animals.

Performed subcutaneous tumor cell implantation.

Accurately measured tumor volume.

Performed protein extraction, solid phase extraction and LC/MS testing.

Administered test material via various routes. Provided quality care and health monitoring for all animals.

Collected and processed biological samples.

Ensured that raw data records were accurate, complete and in appropriate order and met protocol & SOP specifications. Entered and reviewed electronic data.

Served as Lead/ primary technician for studies of standard complexity, including preparation of study specific forms. Followed company SOPs, policies, and practices.

Charles River Labs Inc., Shrewsbury, MA March 2016 – March 2017 (Permanent)

Formulation Technician II

Prepared test articles and substance dosage solutions and suspensions.

Packed, inventoried, and organized return test materials and analytical samples to sponsor.

Assisted in preparing responses to both internal and external quality checks.

Ensured raw data records were accurate, complete, and in appropriate order, and met protocol specifications and/or GLP requirements.

Reviewed documentation of functions performed as part of quality control requirements.

Contributed to department operations improvement in areas such as SOP revisions, department inspections, and equipment maintenance.

Bristol - Myers Squibb Inc., Devens, MA January 2015 – April 2015 (Contract)

Quality Control Analyst

Performed routine testing and data review of raw material samples in addition to, in-process, batch release and stability samples of bulk drug substances in a cGMP compliant environment.

Performed routine assays such as UV-VIS Spectrometry, SDS Page, wet chemical analysis, utility testing (e.g., TOC, conductivity, and gas testing) and more complex assays including various HPLC with Empower Software methodologies (e.g., peptide map and carbohydrate analysis, ELISAs, qPCR bioassay).

Experienced with Trackwise, LIMS, Smart Lab and Powerpoint.

Barrday Inc., Millbury, MA February 2014 – December 2014 (Permanent)

R&D Technician

Operated complex instruments mechanically testing prepregs, resin and panels for tensile, flexure, shear and compression properties.

Physical testing included using parallel plate rheometer, Fourier transform infrared spectroscopy (FTIR), nuclear magnetic resonance (NMR), differential scanning calorimetry (DSC), thermo gravimetric analysis (TGA), cross-sectional digital microscopy, thermo mechanical analysis (TMA) and dynamic mechanical analysis (DMA).

ADDITONAL RELEVANT EXPERIENCE

Genzyme, Inc., Framingham, MA-Manufacturing/Quality Control Associate

ThermoFisher Scientific Inc., Franklin, MA-Quality Control/Column Packing Technician

Vertex Pharmaceuticals Inc., Cambridge, Massachusetts – Quality Control/Senior Scientific Associate

Verax Biomedical Inc., Worcester, Massachusetts – Manufacturing /Quality Control Technician

The Gillette Company, Needham, Massachusetts – Research Associate

Alpha Analytical, Inc., Westborough, Massachusetts – Inorganic Chemist

Biosource International, QCB Division, Hopkinton, Massachusetts – Data Analyst Technician

EDUCATION

University of Massachusetts, Amherst, MA Graduate School

Relevant Courses Completed: Advanced Inorganic Chemistry, Theory of Analytical Processes

Saratov University, Saratov, Russia

B.S. Chemistry

Saratov Academy of Economics, Saratov

Russia B.S. Economics/Business Management

COMPUTER SKILLS

Microsoft Office including Word, Excel, and Power Point

Note:

During my gaps between my full-time employment:

volunteering in the library, dog, rescue,

teaching fitness classes.

taking QA courses.

Contact this candidate