LARISA M. KUBIT

*** ***** ******

SHREWSBURY, MA 01545

Home: ***/***-****

E-mail: ad2x3g@r.postjobfree.com

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 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. Working knowledge of pertinent standards and guidance documents ISO 10993, 21 CFR 58, and FDA Guidance Documents for biocompatibility. Enthusiastic, energetic candidate with a strong work ethic and excellent attendance to details record who works well independently or as part of a team.

Employment:

Astellas Inc., Westborough, Massachusetts

Sr. QC Associate

January 2022- May 2023 (Permanent)

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. Interacted with agents from Regulatory agencies and participated in Pre-Approval Inspections. Completed routine records review of test data and related documents. 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, Massachusetts

QC Review Resource

August 2021-January 2022 (Contract)

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, Massachusetts

Compliance Specialist

November 2020-August 2021 (Permanent)

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 log book review. Provided on the floor support to the operations department. Issued action notices and conducted affiliated provisional release. Conducted log book 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 record and log book issuance. Partnered with manufacturing and support 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, Massachusetts

QC Analyst II

January 2020 – October 2020 (Contract)

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, Massachusetts

Research Assistant II

April 2017 - October 2018 (Permanent)

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, Massachusetts

Formulation Technician II

March 2016 - March 2017 (Permanent)

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, Massachusetts

Quality Control Analyst,

January 2015 - April 2015 (Contract)

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, Massachusetts

R&D Technician

February 2014 - December 2014 (Permanent)

Operated complex instruments mechanically testing prepregs, resin and panels for tensile, flexure, shear and compression properties. Physical testing included using parallel plate rheometry, 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).

Genzyme, Inc., Framingham, Massachusetts

Manufacturing/Quality Control Associate

January 2012 - July 2012 (Permanent)

Operated complex systems and equipment in strict accordance with current GMP's, SOP's, and safety guidelines. Initial job responsibilities included CIP of process equipment and purification/operation of microfiltration and chromatography systems. Assisted and/or lead the implementation of production procedures and equipment guidelines. Performed in-process sample testing, stability testing, raw materials inspection, sampling, and testing, revised SOPs and reviewed documentation. Maintained cGMP of the lab (QC Chemistry and Raw Materials Lab) and followed the actions and rules of all compliance programs (i.e., logbook entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipment and QC daily laboratory maintenance log). Calibrated pH meter, conductivity meter, balance, etc. Managed laboratory purchasing, maintenance of equipment, and inventory.

ThermoFisher Scientific Inc., Franklin, Massachusetts

Quality Control/Column Packing Technician

September 2008 - September 2011 (Permanent)

Responsible for making different kinds of columns according to GMP and exceeded daily goals by 50% on average. Possess an understanding of process theory, equipment operation and working knowledge of manufacturing process following SOP’s. Tested columns on Agilent HPLC and performed troubleshooting of equipment as needed. Prepared test samples and buffers and ordered supplies. Maintained cGMP of the lab (QC Chemistry and Raw Materials Lab) and followed the actions and rules of all compliance programs (i.e., logbook entry and reviews, proper raw material and reagent disposal, temperature monitoring of equipment, QC daily laboratory maintenance log). Calibrated pH meter, conductivity meter, balance, etc. Managed laboratory purchasing, maintenance of equipment, and inventory.

Summary: Prior to Thermo-Fisher Scientific work-related experience includes:

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, Massachusetts

Courses Taken: Graduate Program Fall Semester:

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

Skills: Microsoft Office including Word, Excel, and Power Point

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