Rebecca Gonzalez
San Antonio,TX
Summary
Specializing in quality assurance and regulatory compliance, with significant experience in managing cross-functional teams and audit processes. Proven track record in driving continuous improvement and ensuring adherence to ISO and FDA standards, enhancing operational efficiency and compliance outcomes.
Overview
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1
Language
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Certification
24
24
years of professional experience
Work History
Senior Clinical Quality Assurance Specialist
Boston Scientific
Marlborough, USA
02.2022 - Current
- Collaborated with cross-functional clinical project teams on problem-solving activities and inspection readiness, driving continuous improvement initiatives by assessing compliance with protocols, GCP, applicable regulatory requirements, and relevant BCS policies and procedures.
- Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, processes, procedures, and controls employed in the design, conduct, and analysis of clinical trials through review of the accuracy, validity and quality of the scientific data generate during clinical trials.
- Documented and communicated audit findings to relevant parties; evaluated impact and responses to findings, ensuring identification, implementation, and monitoring of appropriate corrective and preventative actions.
- Assisted in integration of electronic Quality Management System (eQMS) to enhance compliance processes. and eTMF systems integration and continued support working with the SMEs in IT to ensure compliance and make changes according to user requirements.
- Provided support to Clinical teams during internal quality audits to ensure compliance. and QS team during internal quality audits.
- Coordinates/participates in BIMO sponsor inspection, and other regulatory agency sponsor inspections of BSC offices, Preparation of investigator sites for FDA or other regulatory agency inspections and assists in the preparation of written responses to findings.
- Contributes to the development of audit procedures and processes, keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
- Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
- Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners providing quality input.
- Assisted multiple clinical teams in gathering and reporting performance metrics, supporting CQA manager in preparing slides and overall health statements for quarterly management review meetings.
- Executed clinical process improvement projects and initiatives, including training.
- Regularly review, edit, and approve quality documentation including, SOPs, work instructions, forms, regulatory files, templates, in collaboration with associated SMEs, to ensure continued compliance and operational requirements per company and regulatory requirements.
Quality Assurance and Training Specialist-Clinical Research
CNB – U.S. Army Institute of Surgical Research
San Antonio, USA
02.2017 - 11.2021
- Conduct protocol evaluations and feasibility assessments of proposed clinical research in compliance with Sponsor, DoD, Army and FDA requirements.
- Perform all quality assurance responsibilities within the protocol parameters by the Principal Investigator, Sponsor, CRO and Regulatory bodies.
- Assist in the development, execution, and maintenance of a Clinical Quality Management Plan for relevant clinical research studies.
- Facilitate the development and implementation of (study-related) SOPs, DOPs and SSPs, compliance documentation, and tools for assessment.
- Audited and reviewed clinical trial quality assurance efforts and essential documents (paper and eTMR) to ensure compliance with regulatory guidelines (Sponsor, DoD, FDA, etc.).
- Managed USAISR AFIRM document control system, prepared documents for review and signature, maintained tracking system for SOP and SSP status, and issued SOPs/SSPs electronically and in hard copy.
- Coordinate external monitor visits and routine internal audits of adherence to protocols, accountability and ethical requirements as well as relevant Sponsor, DoD and FDA regulations and guidance and recommend and support appropriate corrective actions.
- Serve as liaison between sponsors, investigators, departmental research personnel and other individuals assigned to the study.
- Review source documents of assigned studies, managed data collection, ensured all AEs are identified and reported appropriately.
- Verify entries of required data on paper or electronic Trial Master Records (eTMR) and CRF and audits/reviews records for accuracy and consistency.
- Support and maintain clinical study regulatory readiness for audits in regulatory inspections for the USAISR CRSD program.
- Document resolution of any observations, analyzed data and reported information to appropriate individuals.
- Independently develop quality assurance/quality control training materials and conducted education for team members on specifics of the protocol, study design and investigational therapeutic agents, procedures and/or techniques specific to assigned study and maintained supporting documentation.
- Facilitate the activities of research personnel to ensure quality patient care and adherence to research Good Clinical Practice (cGCP), Good Laboratory Practices (cGLP) and Good Manufacturing Practices (cGMP), GxP requirements.
- Monitored research activity progress, developed and maintained records from inception to closure, and prepared periodic status reports for investigators, administrators, funding agencies, and regulatory bodies.
- Manage the administration of procedures related to the development, implementation, management, evaluation, and continuous quality improvement of organizational operations.
- Coordinate and participate in study team meetings throughout the lifecycle of the study.
Quality Assurance Manager
Vention Medical
Kerrville, USA
04.2015 - 09.2016
- Aided in the transition of Quality Management Systems including development, implementation and maintenance of Standard Operating Procedures and Quality Procedures documentation during a major company acquisition.
- Coordinated the maintenance, monitoring and improvements of the Quality Management Systems including development, implementation and maintenance of Standard Operating Procedures and Quality Procedures documentation using product device master record documentation and auditing processes for quality metrics monitoring in accordance to ISO 9001 and 13485 regulations.
- Functioned as the primary liaison with customer and regulatory auditors, incorporating ISO 9001 and 13485 standards along with cGMP, cGDP, and QSR criteria. Reviewed internal and external audit data to strengthen the Quality Management System's effectiveness.
- Analyzed and submitted quality data narratives monthly, quarterly, and yearly to ensure mitigating factors remained within acceptable limits. Based on trending results, initiated corrective and preventive actions aligned with customer and business quality improvement needs, including field corrections/removals.
- Developed and maintained a corrective and preventive action program and initiated corrective action with key personnel to resolve problems.
- Educated personnel on quality philosophies and practices, providing on-the-job training and development for all shifts. Actively participated as a management team member, ensuring effective communication of quality goals and objectives.
- Strengthened the quality culture within the company by promoting best practices and encouraging staff participation. Developed, led, facilitated and participated in quality improvement teams.
- Participated as a cross-functional team member in projects involving multiple internal departments across all 14 company sites, domestically and internationally, such as Operations, Supply Chain, Engineering, Finance, and Management Review units.
- Coordinated with multiple Information Technology teams on databases and their compliance requirements. Aided in initiating corrective actions by providing feedback for improvements that were aligned for maintaining regulatory compliance.
- Facilitated the manufacturing and shipment of components to other sister domestic and international plants for finished goods assembly.
- Worked closely with customers, vendors, suppliers, and other outside professionals with whom the company deals. Domestic and international communication was gathered from all areas to amass complete compliance data.
- Identified, analyzed and documented any observations relating to product or process. Recommended solutions and verified their implementation and effectiveness of changes and documentation for in-process production. Participate in IQ, OQ, PQ, Gage R&R, Design Of Experiments and PFMEA verifications and validations including all supporting documentation for new and existing components.
- Maintained systems to monitor and facilitate timely investigations and closure of open complaints, ensuring investigations were completed promptly. Communicated through oral, written, or physical contact as needed to support quality assurance and development.
- Provided daily supervision/leadership to a team of Quality Assurance personnel. Engaged in decision-making for the selection, promotion, transfer, compensation, and discipline of all assigned personnel. Assessed their effectiveness and performed performance reviews to support and acknowledge improved performance.
Quality Assurance Complaint Handling Supervisor
Kinetic Concepts, Inc. & ArjoHuntleigh, Inc
San Antonio, USA
06.2009 - 06.2014
- Monitored and analyzed quarterly complaint data to assess mitigating factors, severity, and occurrence levels, ensuring compliance with product risk documentation and guiding CAPA investigations.
- Ensured root cause investigations and complaint data analysis were performed aiding in the development and maintenance of risk documentation of critical care products in accordance with company and Competent Regulatory Agencies policies, procedures and regulations.
- Designed and implemented system enhancements that streamlined the complaint handling process, improving response times and accuracy.
- Aided in the transition of Quality Management Systems including development, implementation and maintenance of Standard Operating Procedures and Quality Procedures documentation using product device master record documentation and allegation codes to enhance accuracy of the auditing process for quality metrics monitoring.
- Briefed and collaborated with executive team leaders, including Vice Presidents and Senior Directors, to resolve operational issues impacting quality metrics, risk management, and compliance.
- Served as liaison with regulatory agencies providing quality oversight with regulatory bodies such as FDA, ISO, MHRA, and Health Canada, integrating cGMP and QSR criteria.
- Collaborated with multiple departments, including engineering, R&D, post-market surveillance, risk management, supplier quality engineering, field service, legal, medical, and management review, to gather compliance data.
- Provided significant involvement in both internal and external audits throughout tenure. Conducted personnel training within all appropriate departments.
- During major company acquisition, coordinated the complaint handling integration project with both companies to align and provide synergy regarding medical device interpretations, focus, and regulations.
Assembly Supervisor
Kinetic Concepts, Inc.
San Antonio, USA
11.2002 - 12.2007
- Led a 30 member team in all aspects of daily production. Managed qualitative and semiannual performance reviews including personnel counseling to ensure top employee production levels.
- Managed production phases from receipt of raw materials throughout assembly, packaging, and shipping.
- Effectively coordinated with multiple departments regarding the implementation of new products into the production line. Collaborated with engineering, procurement, quality assurance, calibration and R&D to ensure on-time launch launches in accordance with product development procedures.
- Managed inventory control, in addition to budgets and production performance levels to maintain cost efficiency. Completed timely analysis of work order labor and material variances.
- Conducted continuous training regarding SOP’s, quality, safety, ISO 9000, and FDA requirements.
- Implemented ongoing engineering changes and deviations, and conducted root cause analysis regarding materials, quality, and assembly processes.
- Successfully completed training and implemented Lean Manufacturing concepts which included Just In Time Delivery and One Piece Flow Manufacturing.
- Co-authored work instructions, testing procedures, and appropriate documentation for production.
- Promoted to Quality Assurance for excellence in job performance. Continually produced quality operations on behalf of high dollar product lines.
Education
Bachelor of Business Administration - International Business
University of Texas at San Antonio
Skills
- Clinical quality management
- Quality audits
- Compliance monitoring
- Regulatory docs
- Clinical trial oversight
- Corrective actions management
- Risk management
Professional Development
- ISO 13485:2016 Lead Auditor Certified
- ISO 13485:2003 Lead Auditor Certified
- Clinical Project Management Certification
- Clinical Research Auditing Certification
- Training: ISO 14155:2020 WMDO Certificate
- ISO 14971:2019
- ISO 9001:2015 Regulations and Requirements
- The FDA Inspection Process: From SOP to 483
- Key Factors to Write and Effective SOPs and WIs
- Medical Device Complaints: Strategies for Managing Your Biggest Compliance Challenge
- Compliant Device Design
- CITI Certified
Languages
Spanish
Professional
Certification
- ISO 13485:2015 Lead Auditor
Timeline
Senior Clinical Quality Assurance Specialist
Boston Scientific
02.2022 - Current
Quality Assurance and Training Specialist-Clinical Research
CNB – U.S. Army Institute of Surgical Research
02.2017 - 11.2021
Quality Assurance Manager
Vention Medical
04.2015 - 09.2016
Quality Assurance Complaint Handling Supervisor
Kinetic Concepts, Inc. & ArjoHuntleigh, Inc
06.2009 - 06.2014
Assembly Supervisor
Kinetic Concepts, Inc.
11.2002 - 12.2007
Bachelor of Business Administration - International Business
University of Texas at San Antonio