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Sharlynn
Principal Quality Assurance Engineer
Contato
Competências
Experiencia demostrada en Quality Assurance Engineering.
Experiencia demostrada en Process Improvement.
Experiencia demostrada en Project Management.
Experiencia demostrada en ISO13485.
Experiencia demostrada en ISO9001.
Formação acadêmica
Idiomas
Resumo
Principal Quality Assurance Engineer buscando nuevas oportunidades
Experiência
Quality Engineer
Develop and implement quality programs, including tracking, analyzing, reporting, and problem-solving.. Plan, control, and assure product and process quality in accordance with established quality principles such as planning processes, material control, acceptance sampling, and measurement systems.. Develop technical documentation such as Validation Protocols, Technical/Investigation Reports, SOPs, Validation Plans, Change Controls, and other related documents.. Qualify new facility additions, including HVAC and water filter systems.. Ensure compliance with ISO cleanroom standards and FDA regulations in a regulated environment.. Understand and execute the audit process, including types of audits, planning, preparation, execution, reporting results, and follow-up actions.. Analyze and acquire data using appropriate standard quantitative methods for process analysis and improvements.. Work on problem-solving and quality improvement initiatives using various tools and techniques.. Develop and maintain a thorough understanding of reliability, maintainability, and risk management in relation to quality systems.. Interact cross-functionally with various departments to ensure compliance and process improvements.
Quality Engineer Process Development
Reviewed and approved technical documentation related to quality and validation activities.. Developed and executed validation protocols for equipment and processes.. Performed Statistical Process Control (SPC) and data analysis to support process improvements.. Executed equipment qualifications and managed calibration activities.. Investigated non-conformities and participated in root cause analysis (RCA).. Developed and implemented corrective and preventive actions (CAPA).. Collaborated with Research & Development (R&D) for product development initiatives.. Supported implementation of new products and equipment into manufacturing.. Managed change control documentation to ensure regulatory compliance.
Supplier Quality Engineer
Performed supplier qualification activities, defect resolution, performance monitoring and reporting for global suppliers.. Developed, reviewed, and approved Master Validation Plans, Qualification Protocols, Process Flow Diagrams, Test Method Validations, and Computer System Validations (CSV).. Executed investigations, including root cause analysis (RCA), non-conformance reporting, and implementation of corrective and preventive actions (CAPA).. Served as QA technical and compliance point of contact for component suppliers, supporting collaboration with global cross-functional teams.. Promoted continuous improvement initiatives by supporting the proper disposition of non-conformances and leading efforts to identify and resolve issues.. Participated actively as Subject Matter Expert (SME) in manufacturing-related meetings and projects, ensuring alignment of documentation, specifications, and drawings with quality standards.. Served as a core member of the Material Review Board (MRB), contributing to compliance verification and deviation report analysis.. Supported and documented validation and qualification efforts, including EtO sterilization processes for finished goods.. Monitored compliance data and trends related to sterilization and quality processes, ensuring adherence to regulatory requirements.. Provided technical input on process diagrams, method validations, and controlled documentation for sterilization activities.
Sr. Quality Assurance Investigator Engineer
Managed Non-Conformance Exception Reports (NCEs), complaints investigations, and Product Quality Reviews (PQRs) for products manufactured at AbbVie.. Served as the primary quality liaison between site quality and departments including MS&T, Supply Chain, Operations, Incoming, Engineering, Third Party Manufacturers (TPM), and Third-Party Contractors (TPC).. Monitored and promoted continuous improvements in the CAPA quality system to ensure compliance and process efficiency.. Led complaint investigations and maintained the PQR system, ensuring proper documentation and analysis of product performance data.. Generated PQRs for each product list number manufactured, incorporating data such as change control, exception events, in-process tests, stability, validation, regulatory issues, and recalls.. Performed statistical analysis and generated trend reports to evaluate product performance and identify quality trends.. Conducted track and trend analysis of investigations to identify quality issues, with monthly reporting of investigations metrics.. Reviewed periodic quality metrics related to investigations, complaints, PQRs, and other KPIs as requested by area management.. Collaborated with Manufacturing and Engineering teams to ensure alignment with quality systems, regulatory standards, and continuous improvement initiatives.. Led evaluations of product performance trends, focusing on product quality and regulatory compliance.
Sr. Quality Assurance Scientist
Provided scientific guidance and Quality Assurance direction for the approval of GMP documents, including Batch Records, protocols, procedures, qualification, and validation reports.. Applied critical analytical thinking during the investigation management process, particularly in Root Cause Analysis (RCA), Risk Assessment (RA), and Corrective and Preventive Actions (CAPA) determination.. Oversaw manufacturing operations as required by the New Product Introduction (NPI) process and served as the QA liaison between APL and Third-Party Manufacturers or Third-Party contractors.. Led and participated in the review of documents associated with manufacturing operations, release, packaging, and related activities in the operations area.. Actively participated in investigations within the manufacturing area (OSD and Parenteral products), Warehouse, and Microbiology laboratory, providing support from a Quality perspective.. Participated in Manufacturing Alignment Teams (MAT), Project Alignment Teams (PAT), department staff meetings, planning, and Change control board meetings (CCB).. Evaluated documentation compliance for all manufacturing and support areas, including CR’s, SOP’s, BR’s, BOM’s, and WPP’s, in accordance with government regulations and Company policies.. Verified instrumentation and equipment calibration records and critical area engineering drawings.. Reviewed product and computer systems validation protocols, reports, and change control documents.. Approved or rejected procedures impacting drug products, raw materials, or packaging components.. Ensured proper designation and monitoring of storage conditions for quarantine materials and products.
Quality Engineer
Led continuous process improvement initiatives within the Quality and Manufacturing departments, including conducting Risk Assessments, process-specific training, validation, and investigations.. Identified manufacturing process defects and non-conformance issues, implementing corrective actions.. Utilized quality and lean manufacturing tools such as Lean Six Sigma and DMAIC methodology to drive process improvements.. Participated in Product Transfer activities, ensuring smooth integration and compliance with quality standards.. Assisted in regulatory inspection readiness, supporting preparations and addressing inspection findings.. Reviewed, documented, and approved IQ-OQ-PQ validation protocols and reports to ensure adherence to regulatory standards.. Analyzed issues related to Abbott Vascular procedures, recommending solutions and improvements based on data analysis.. Supported and documented Process Change Requests (PCRs) and regulatory compliance documentation, including ECRs.. Performed investigations and remediation activities, identifying root causes and implementing CAPA (Corrective and Preventive Actions).. Facilitated completion of tasks in line with project schedules and business needs.. Assisted in conducting audits to drive process standardization, waste elimination, and continuous improvement efforts.. Ensured compliance with safety, environmental regulations, and company policies, contributing to the delivery of high-quality products to customers.
Quality Engineer II
Designed and implemented quality control processes, sampling systems, procedures, and utilized SPC (Statistical Process Control) techniques to ensure product quality.. Specified and documented inspection and testing mechanisms, including TMV (Test Method Validation) and Process and Equipment Qualification (IQ/OQ/PQ).. Contributed to analyzing manufacturing production limitations, applying standards, and implementing continuous improvement initiatives such as Lean and Kaizen.. Investigated quality-related issues and supported the implementation of Corrective and Preventive Actions (CAPA) to address identified problems.. Recommended and implemented revisions to manufacturing specifications and Standard Operating Procedures (SOPs).. Assisted in the formulation and development of quality control policies and procedures.. Verified and approved quality-related documentation, ensuring compliance with regulatory standards.. Analyzed manufacturing process defects and non-conformances, recommending potential solutions and improvements.. Supported process improvement initiatives aimed at increasing efficiency and product quality.. Provided support for the validation of new and existing products and processes, including cleanroom validations and experimental trials.
Quality Engineer
Wrote and approved procedures, validation protocols, IQ/OQ/PQ, MVP, VRP, and other documentation essential for process improvement and quality systems.. Developed and provided training to the manufacturing team on procedures and equipment to ensure adherence to quality standards.. Performed troubleshooting, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control) application, and ensured compliance with QSR/ISO requirements.. Analyzed issues related to inspections and procedures, made decisions, and recommended possible solutions and improvements.. Created reports, evaluated studies, and contributed to the qualification of new products (NPI) or processes to ensure their quality and reliability.. Reviewed and approved qualification/validation documents and reports, including EQPs, ECOs, PCRs, ECRs, process changes, quality records, and manufacturing documentation.. Reviewed and analyzed quality trends with the manufacturing team, providing guidance on process enhancement priorities.. Participated in KAIZEN events and Lean Six Sigma activities to foster continuous improvement.. Supported Product Transfer activities to ensure seamless integration of new products and processes.. Led effective in-depth investigations, supported technical teams to identify root causes of nonconformance, and ensured that sound Corrective and Preventive Actions (CAPA) were implemented.. Evaluated the effectiveness of CAPA to ensure their long-term success in improving product quality and process reliability.. Provides support to validation of new and existing processes.. Coordinates and provides technical support on new product introduction, NPI, and product transfer activities, including data gathering and analysis, sampling, and validation.. Comply with applicable safety, environmental regulations and company standards and policies to help ensure the delivery of highest quality products to the customer.
Quality Analyst Engineer
Contributed to the introduction of new Drug of Abuse (DOA) medical devices, UDI, GUDID, ensuring compliance with FDA regulatory requirements.. Led validation activities for project implementation, including the development of the Master Validation Plan (MVP) and reports.. Developed and executed validation protocols (IQ/OQ/PQ, VP, CSV) to optimize and validate manufacturing processes and equipment.. Conducted validation execution and training activities for operators and technicians to ensure proper equipment and process handling.. Designed testing plans to qualify new equipment and validate computer software to improve process output and contribute to process improvement.. Utilized and evaluated sampling plans to apply a statistical-based approach for process validation, in compliance with the Code of Federal Regulations.. Applied basic and advanced statistical methodologies (SPC, DOE) to design and execute validation protocols.. Analyzed and interpreted results in Excel and Minitab for gauge R&R and ANOVA studies.. Provided on-site assistance during FDA and internal audits, ensuring compliance with regulatory standards.. Developed documentation for production process qualification, equipment qualification, and validation assessments.. Actively participated in the Engineering Change Control and Quality Assurance committees to ensure quality standards and improvements.. Contributed to sustainment projects related to internal manufacturing, including production/process enhancement initiatives, LEAN/KAIZEN activities, efficiency improvements, and corresponding validation, equipment purchases, procedure documentation, and training.. Evaluated FMEA, Root Cause Analysis, CAPA, and provided recommendations to resolve audit findings and improve quality systems.