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Click here or scroll down to respond to this candidateCandidate's Name
Street Address SOUTH STREETSHREWSBURY, MA Street Address
Mobile: PHONE NUMBER AVAILABLEE-mail: EMAIL AVAILABLECareer 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 laboratorys operations are according to regulatory standards and accreditation regulations. Enthusiastic, energetic candidate with a strong work ethic and excellent attendance to detail record who works well independently or as part of a team.Note: I have a part time job as a Fitness Instructor and during my gaps between my full-time employment I am teaching fitness classes.Employment:Dupont Inc., Marlborough, MassachusettsR&D Associate-Analytical ChemistApril 2024 September 2024 (Contract)Work 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 molecule 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.Astellas Inc., Westborough, MassachusettsSr. QC AssociateJanuary 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 SOPs, 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, MassachusettsQC Review ResourceAugust 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, MassachusettsCompliance SpecialistNovember 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 logbook review. Provided on 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 record and logbook issuance. 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, MassachusettsQC Analyst IIJanuary 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, MassachusettsResearch Assistant IIApril 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, MassachusettsFormulation Technician IIMarch 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, andmet 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, MassachusettsQuality 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, MassachusettsR&D TechnicianFebruary 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 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).Genzyme, Inc., Framingham, MassachusettsManufacturing/Quality Control AssociateJanuary 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, MassachusettsQuality Control/Column Packing TechnicianSeptember 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 SOPs. 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, MassachusettsQuality Control/Senior Scientific AssociateVerax Biomedical Inc., Worcester, MassachusettsManufacturing /Quality Control TechnicianThe Gillette Company, Needham, MassachusettsResearch AssociateAlpha Analytical, Inc., Westborough, MassachusettsInorganic ChemistBiosource International, QCB Division, Hopkinton, MassachusettsData Analyst TechnicianEducation:UNIVERSITY OF MASSACHUSETTS Amherst, MassachusettsCourses Taken: Graduate Program Fall Semester:Advanced Inorganic Chemistry,Theory of Analytical ProcessesSARATOV UNIVERSITY Saratov, Russia B.S. ChemistrySARATOV ACADEMY OF ECONOMICS Saratov, Russia B.S. Economics/Business ManagementSkills: Microsoft Office including Word, Excel, and Power Point |
