Benjamin La Bonte

Benjamin LaBonte linkedin.com/in/benjamin-labonte Quality Assurance Specialist | Current Good Manufacturing Practices (cGMP) Compliance | Root Cause Analysis (RCA), including 5 Whys, Fishbone, and 6M | Document Control and Deviation Tracking Systems Professional Summary Detail-oriented Quality Assurance professional with 10+ years of experience in regulated environments, including biotech, pharmaceutical, and medical device manufacturing. Demonstrated success in maintaining quality compliance, conducting internal audits, and optimizing documentation systems. Proficient in batch record review, Current Good Manufacturing Practices (cGMP) compliance, ISO 13485 (Lead Auditor Certified), and ICH Guidelines auditing. Adept in SAP-based quality systems, ensuring timely and accurate product release across multiple manufacturing stages. Skilled in driving operational excellence and continuous improvement through data-informed decision-making and cross-functional collaboration. Implemented targeted process enhancements that reduced recurrence of deviations and improved CAPA effectiveness. Streamlined investigation workflows through Lean principles, accelerating closure timelines while maintaining documentation quality and regulatory compliance. Recognized for being collaborative, adaptable, and dependable in fast-paced, quality-driven environments. Key Skills Quality & Compliance • cGMP, GLP, GDP, FDA-Regulated Environments, Quality Assurance (QA), Batch Record Review, Product Release, Document Control, Data Integrity, Risk Assessment, DHR/MPS Documentation Auditing & Investigations • ISO 13485 (Lead Auditor Certified), Internal Audits, Quality Audits, CAPA, Nonconformance Investigations, Root Cause Analysis (RCA), Complaint Handling Process Improvement • Lean Manufacturing, Six Sigma (Yellow Belt Certified), DMAIC, Process Mapping, Change Management, Deviation Handling, Continuous Improvement, Operational Efficiency, Statistical Process Control (SPC) Technology & Systems • SAP, Movex (Infor M3), Predisys, MasterControl (QA & Document Control), Microsoft Office Suite (Excel, Word, Outlook) Communication & Documentation • Stakeholder Engagement, Regulatory Correspondence, Deviation Report Writing, CrossFunctional Collaboration, Training Delivery, Regulatory Submission Readiness Certifications • ISO 13485 Lead Auditor Certification, 160332 – Issued June 2021 • Lean Six Sigma Yellow Belt Certification – Issued October 2024 Education Douglas Education Center, Monessen Associates Degree in Specialized Business Montachusett Regional Vocational Technical School Diploma / Certificate in Auto Body Professional Experience QA Compliance Specialist I Anika Therapeutics, Inc. | Oct 2019 – Mar 2025 • Supported organizational growth by leading and participating in quality-driven, compliancefocused improvement initiatives. • Reviewed and approved batch records, Certificates of Analysis (CoAs), supplemental logs, charts, and documentation for cGMP operations and final product release. • Released and maintained Master Part Specifications (MPS) for raw materials and components. • Provided QA oversight for investigations including nonconformances, CAPAs, root cause analysis, product complaints, out-of-specification (OOS) results, and environmental excursions. • Managed quality documentation for change controls, planned deviations, and document control systems. • Maintained accurate and complete Device History Records (DHRs) to ensure traceability and compliance. • Served as Lead Auditor for quarterly onsite walkthrough audits; authored and owned monthly audit reports. • Provided QA support for pre- and post-shutdown activities, ensuring readiness and compliance. Quality Assurance Technician Pharmasol Corporation | Jul 2019 – Aug 2019 • Applied knowledge of Good Manufacturing Practices (GMP) to ensure compliance in daily QA activities. • Logged, tracked, and processed customer complaints through to resolution in accordance with company procedures. • Participated in quality investigations related to product issues and complaint trends. • Supported documentation and closure of complaint records to maintain regulatory readiness. Manufacturing Quality & Inspection Technician — GE Healthcare Bio-Sciences Corp (Dec 2017 – May 2019) • Performed incoming, in-process, and final inspections to ensure product conformance to Specifications. • Applied GMP, GDP, and GLP principles; maintained adherence to calibration, ESD, preventive maintenance, and material segregation requirements. • Reviewed documentation for accuracy, completeness, and compliance with GEHC’s Quality Manual and QMS policies. • Ensured regulatory alignment with FDA and industry standards; identified and reported compliance issues with swift corrective actions. • Reviewed and edited external communications, site policies, SOPs, and forms for formatting, consistency, and procedural accuracy. QA Technician / Quality Inspector — Nypro Healthcare, a Jabil Company (Nov 2015 – Oct 2017) • Reviewed and released batch records, ensuring cGMP corrections were made and all documentation met compliance standards. • Entered traceability data into LPM and SAP systems, verified and approved Certificates of Compliance for product release. • Performed AQL sampling and inspections in response to nonconformities. • Collaborated with quality inspectors to address real-time issues and implement corrective actions based on SOPs and work instructions. • Provided on-the-floor support to ensure compliance with GMP practices during production. • Conducted visual, dimensional, mechanical, and functional inspections of raw materials, inprocess components, and finished products. • Applied inspection procedures using gauges, tools, and equipment to confirm product conformance to specifications. • Maintained and reviewed Batch History Records (BHR) and Device History Records (DHR) for completeness and accuracy. • Determined disposition of defective items and documented findings per quality control procedures. • Followed written procedures, blueprints, and diagrams; performed in-line sampling and inspections at various production stages. • Entered Statistical Process Control (SPC) data into Predisys for trend analysis and quality tracking. Terminal Operator (Temp) — Cargill Milling Inc. (May 2015 – Oct 2015) • Monitored and controlled dispatch schedules to ensure timely delivery of sweetener products to customers. • Coordinated with clients and adjusted dispatch logistics to accommodate last-minute changes or additions. • Liaised with the rail team to manage accurate product switches and shipments. • Maintained inventory levels by tracking and reordering routine operational supplies. • Performed manual tasks including hose handling (3”–4”), flange transportation, and basic equipment repair support. • Assisted with maintenance tasks and minor equipment repairs to support terminal operations. QA Technician — Dav-Tech Plating, Inc. (Feb 2015 – May 2015) • Reviewed blueprints to verify critical dimensional tolerances and ensure product compliance. • Performed in-process measurements and nondestructive testing on finished products to evaluate structural and functional integrity. • Conducted assessments for adhesion strength, surface roughness, plating thickness, and color Uniformity. • Provided guidance to production teams to align processes with customer specifications and quality standards. • Supported and maintained ISO 9001 and AS9100 certifications for surface treatment applications and part fabrication per client requirements. Quality Assurance Technician II — Haartz Corporation (Oct 2011 – Oct 2014) • Performed both destructive and nondestructive testing to assess material and product performance, durability, and key characteristics. • Conducted evaluations for appearance, dimensional accuracy, and chemical properties to ensure adherence to specifications. • Inspected products throughout various production stages and compiled statistical data to support quality and reliability standards across the manufacturing process. Quality Control Laboratory Technician — Teknor Apex (Jul 2008 – Sep 2011) • Conducted raw material and finished product testing to ensure compliance with TPE business quality standards. • Prepared samples using injection molding, compression molding, and die cutting techniques for accurate and repeatable results. • Analyzed test data, compared results to specifications and SPC trends, and initiated first-level investigations into deviations or non-conformities. • Maintained compliance with ISO 9001/QS 9000 quality systems and contributed to continuous improvement initiatives. • Utilized SAP, Movex, and Microsoft Office Suite for data entry, reporting, and documentation.