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Click here or scroll down to respond to this candidateCandidate's Name
1 Arizona Terrace, Arlington, MA Street Address EMAIL AVAILABLE PHONE NUMBER AVAILABLESUMMARYHighly-motivated Quality Assurance professional with a background in pharmaceuticals and medical device design and manufacturing. Experience leading projects of moderate to high complexity associated with process improvement, CAPAs, and change controls. Proactively address nonconformities to improve manufacturing flow and product quality.SKILLSQuality system auditing and reportingInspection readinessISO 9001, ISO 13485, ISO 14971 PIC/S, WHO-GMP, EudraLex, and FDA 21 CFR 210, 211 & 820Quality risk and impact assessmentsQuality record initiation, review, and approval in TrackWise QMS (QEs, CAPAs, CCs)Lean Six Sigma methodologiesInvestigation RCA tools (5 Whys, Fishbone Diagrams, FMEAs)MS Office (Word, PowerPoint, Excel, Access)MS SharePoint, Agile, Smartsheet, and project management platformsMS Dynamics AX and SAP ERP systemsPROFESSIONAL EXPERIENCEQuality Specialist III (Dec 2023 Jul 2024)Thermo Fisher Scientific, Lexington, MACollaborated cross-functionally to successfully implement product/process changesSupported the fulfillment of backroom requests for external audits, ensuring timely and accurate delivery of required documentation and dataAttended daily triage meetings with stakeholders for review and assessment of QEs to determine the level of priority to escalateFacilitated weekly Quality meetings with clients to review the status of record approvals and open investigations, ensuring timely resolution and compliancePerformed Quality review/approval of QEs, CAPAs, and CCs in TrackWiseDeveloped deviation awareness training material in collaboration with SMEs and supported the writing of thorough investigationsReviewed/approved unexecuted batch records, ensuring adherence to regulatory standardsParticipated in Kaizen initiatives to streamline the batch record approval process and client communicationEngaged as an Ambassador in activities aimed at fostering teamwork, enhancing open communication, and promoting inclusivityQuality Assurance Specialist III (Nov 2022 Oct 2023)Curia Global, Inc., Burlington, MAMaintained quality system metrics for Management ReviewConducted weekly meetings with stakeholders for review of open quality records to determine the level of priority to assess, triage, and escalate, achieving an 80-90% reduction in overdue recordsFacilitated weekly CRB meetings to evaluate quality issues and ensure the appropriateness of CAPAs and resourcingPerformed QA review and approval of QEs, CAPAs, and CCs in TrackWise Digital, assessing the impact to GMP compliance, product quality, and patient safetySupported manufacturing in writing investigations, ensuring the appropriate use of RCA toolsReviewed executed and unexecuted batch records, and validation protocols and reportsReviewed and approved SOPs and material specificationsPERSONAL DEVELOPMENT (May 2022 Nov 2022)Completed LinkedIn Learning courses, including: Quality Management for Operational Excellence, Project Management Foundations: Risk, Strategic Thinking, Agile Change Management for Manufacturers, Supply Chain and Operations Management Tips, Six Sigma: Black BeltQuality Engineer (Jan 2022 - May 2022)Draeger Medical Systems, Inc., Andover, MADeveloped a prioritization system for open deviations and CAPA recordsFacilitated the closure of QEs and CAPAs resulting from internal audit findings, providing one-on-one RCA support to responsible functional groupsOrganized weekly CRB meetings with Quality and executive management to discuss current status of open records, pending actions, and issues requiring escalationProvided backroom leadership and FDA inspection supportActed as a scribe during Management Review, recording meeting minutes, including key discussion topics, decisions, assigned action items, responsible departments, and completion timelinesSr. QA Specialist (May 2021 - Dec 2021)Sun Pharmaceutical Industries, Billerica, MAAssessed risk and impact to GMP compliance, product quality, and patient safety for assigned QEs, CAPAs, and CCs in the TrackWise QMSEvaluated QE investigations, ensuring proper utilization of RCA tools, and appropriateness of root cause and assigned CAPAsConducted AQL sampling and inspections on the manufacturing floor for intermediates, APIs, and finished product labeling & packaging to ensure compliance with approved specificationsPerformed area and line clearances on the manufacturing floor for filling, inspection, and labeling & packaging areas before the start of operations, as well as after post-batch clearing and cleaning activitiesReviewed completed batch production, quality control, and labeling & packaging records, ensuring that batches were of acceptable quality and produced within a state of controlExecuted transactions in SAP to make usage decisions for inspection lots, and perform stock postings for inspection lots created on the basis of goods movements (to unrestricted/restricted-use stock)Updated SAP Material Master data to define quality inspection/retest intervalsExecuted where-used transactions in SAP to determine product scope for quality-related events and change controlsReviewed test protocols and reports in support of finished product releasesSupported resolution of SAP and QMS-related technical issuesSourcing Continuity Engineer (Oct 2019 - Oct 2020)Medtronic, Danvers, MAPerformed evaluations regarding impact to sourcing continuity and product quality for supplier processing and equipment changesExecuted SAP transactions to review inventory on hand and assess the impact of raw material changes on supply continuityReviewed qualification and validation protocols for compliance with GMP/ISO requirementsAssessed risk for laboratory consumables based on product contact materials and other relevant factorsSupplier Quality Engineer (Jun 2017 - May 2018)Insulet Corporation, Billerica, MAPartnered with Procurement to onboard new suppliers to the ASL, ensuring the completion of self-assessments and acquisition of valid ISO certificationsMaintained over 500 supplier records to EU MDR requirementsPerformed supplier risk assessments to assign appropriate qualification requirements and monitoring activitiesFacilitated supplier audits, documenting observations and reporting findings using knowledge of ISO 13485 and cGMPsPerformed visual inspections of product samples to support investigations of lot qualification failuresEvaluated supplier responses to corrective action requests for effectivenessPrepared ECOs for updating SOPs, BOMs, and product labeling documentationGraduate Researcher - Medical Plastics Design and Manufacturing (Oct 2016 - May 2017)University of Massachusetts, Lowell, MAPrepared an SBIR Phase I grant proposal, demonstrating technical and commercial feasibility of a user-customizable pain management device for Rheumatoid ArthritisApplied knowledge of FDA medical device classification system, MAUDE database, and CDRH guidance documents to prepare a 510(k)EDUCATIONUniversity of Massachusetts, Lowell, MABachelor of Science, Biology (Fall 2016)Graduate Certificate, Medical Plastics Design & Manufacturing (Spring 2017) |
