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Click here or scroll down to respond to this candidateTECHNICAL SKILLS:BSI: CE Mark CertificateBSI: ISO Street Address Auditor Certificate15+ years of experience in Quality Assurance at an operational/management level supporting manufacturing and quality control in a pharmaceutical and biotech environment.Regulation (EU) 2017/745 and 2017/746 of the European Parliament and of the Council. Harmonizing the rules for high standards of quality and safety for medical devices to meet common safety concerns of the products.Manage a risk-based supplier qualification program, including qualification of suppliers, supplier corrective actions, supplier audits and review of Quality Agreements. Write, coordinate, compile, manage and submit Regulatory documents to FDA and other Regulatory Agencies, including International Authorities.Lead auditor for FDA form 482 (form for inspection) and lead meetings with the FDA, answering FDA inspector's questions.Lead Quality Management System (QMS) development, implementation, and execution to US and international regulations and standards, including compliance to Medical Device Single Audit Program, USP regulations, ISO 13485, ISO 9001, ISO 14971, ISO 22716, 21 CFR Part 11, 21CFR 210, 21CFR 211, 21CFR 630, 21CFR 820, 21CFR 860, GMP, GLP and conducted supplier/manufacturer audits.Conduct batch/product release activities and acceptability determination for subassemblies and finished products.Computer Skills: MS Word Office, Master Control, LIMS, SAP, DMS, Track Wise QMS and Internet Explorer.Using the fishbone analysis, six sigma tools and root cause analysis to resolve non-conformance investigations.Tracking and trending, using KPI data to provide an analysis adherence to government standards and FDA for medicinal and medical production.Resolving and Handling Change Controls, Customer Complaints, CAPA, Deviations, and Recalls.IQ, OQ and PQ for validation projectsConducting internal/external audits, safety inspections and material management duties.PROFESSIONAL EXPERIENCE:DxNow, Inc. Aug 2021-PresentQuality Systems ManagerProvides leadership on development and maintenance of quality system, and procedures that ensure QMS compliance with policies that conform to international standards, authorities and regulatory guidelines. In the area of QMS for (i.e. Training, Management Review, Risk Management, Documents/Records Control, Change Management, CAPA, Quality Audit - internal/external, etc.)Provides expert knowledge assessment and guidance in interpreting regulatory and authorities regulations. Performing QMS gap analysis and implementation of improvements to align on regulatory/standard changes compliance. Keeping up to date on applicable FDA, Medical Device Single Audit Program MDR 2017/745, ISO, authorities, and other applicable industry requirementsImplementation and management of Document Control/Quality Records processes and personnel, internal audit Program and audit team, management of central CAPA process and records and management of site Training program, processes, and records.Palmero Healthcare Dec 2019-Jul 2021Sr. Quality Systems ManagerProvides leadership and coaching to all direct reports, includes performance assessment & individual development plan establishment.Review SOPs, work instructions and qualification documents to support operations readiness and technical transfer activities.Regulation (EU) 2017/745 for dental instruments and Medical Device Single Audit Program (MDSAP).Develops and implements Quality on the floor processes, raw material release, batch release, accession, and visual inspection.Reviews batch-related documentation, Electronic batch records and ensures resolution of issues to release product.Prometic Biotherapeutics Oct 2018-Nov 2019QA SupervisorPerforming training, document approval and QA duties in both manufacturing and pre-clinical research, you will support to manufacturing operations, manufacturing Cell therapy products for clinical use based within their GMP manufacturing suite.Quality support for process development work for new clinical trial products and review and approval of documents including batch records, SOPs and validation/qualification plans and reports. Clinical laboratory testing to GCLP and for quality related clinical operations under GCP.EKF Life Sciences/Diagnostics Oct 2017-Oct 2018QA ManagerRegulation (EU) 2017/746 for IVD devices (formally Medical Devices Directive, MDD), Medical Device Single Audit Program, MDR 2017/745, ISO 13485, ISO 14971, 21CFR210, 21CFR 211, 21CFR820, 21CFR58, 21CFR Part 11, USP 71). Lead the interface with the Customers technical teams as well as the business development group to align and deliver compliant and efficient outcomes around securing new business and on boarding of new services.Leadership of the site Risk Management approach [e.g. FMEA and other processes] and assessments of change controls ensuring consistency is part of the role. Lead the functions beyond the normal scope of task-based activities. Knowledge, experience, personal drive, and creativity for new ideas to senior management that will help develop the culture and business of the organization over the next years. Conduct and/or participate in customer meetings and attend off-site meetings. Interact with customers to determine requirements for new projects. Participate in new product introduction and lead technical transfer activities.Train, coach and mentor the team. Interviewing, hiring, and training employees; staffing, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.EternoGen, LLC. Oct 2015 Sep 2017Training and Development Coordinator/Quality Assurance Specialist IVProvide regulatory guidance and support to a wide variety of manufacturing and compounding groups in the NIH intramural program. This will include guidance on development of quality management systems, facility design, and risk management, event reporting and tracking as well as coordinating general support functions.Ability to partner and provide sound guidance at all levels within a complex clinical research setting is key in the performance of duties associated with this position.Posse exceptional communication skills, and a high level of expertise leading, consulting and advising a diverse workforce and running patient care operations in a complex medical setting.Developing the quality assurance and improvement program to align with ISO 13485:2016 (E) and 21 CFR 820.Leading and participating in various Corporate Audit Division strategic initiative committees.Developing and managing project strategy, leading team efforts, overseeing deliverables, resolving issues and prioritizing actions. Regulations: Regulation (EU) 2017/746 for IVD devices (formally Medical Devices Directive, MDD), Medical Device Single Audit Program (MDSAP), ISO 13485, ISO9001, 21CFR210, 21CFR211, and 21CFR820.Batch record review, GMP, GLP and laboratory data results.Design and apply assessment tools to measure training effectiveness.Track and report on training outcomes.Participates in product design dossier and risk assessment for Class III medical devices.Participates in professional and technical knowledge by attending workshops, and seminars.Qualtek Consultants (Contract) Apr 2014 Apr 2015Sr. Mfg. Engineer II/Quality EngineerCompleted process validation for processes and products including IQ, OQ, PQ and Validation Protocols.Created and reviewed PFMEAs, Feature Inspection Plans, and Measurement Instruction sheetsRegulatory support and development of a Pre-Market Approval documentation package for medical Class III medical devices.Monitor and reporting of key quality metrics and performance through trending of key process i.e. CAPA, Change Control, Internal Audit, Trainings etc. and identify metric monitoring or reporting improvementsMedical Device Single Audit Program (MDSAP)Virginia College/Centura College/Miller-Motte College/Med Tech College Jun 2011 Apr 2014Medical Professor (PT)Taught clinical laboratory, phlebotomy, ECG, pharmacology, HIPAA policies and medical terminology.Proactively identified risks, issues, and action items leading to possible solutions; risk resolution techniques highly desired, including mitigation, transference, avoidance, and where required, acceptance.Prepared blood for screening, proper labeling and centrifuging the specimen.Assisted patients regarding HIPPA policies and medical procedures before, during and after collection of specimens.Teaching and organizing program of practical and technical instruction, including demonstrations of skills required in the medical assistant profession, and lectures on theory, techniques, and terminology.Octapharma AG Oct 2007 Jun 2011Quality Assurance SupervisorCoordinated with the projects Independent Validation and Verification entity regarding Quality Audits, requirements validation, and total quality management.Directly supervises quality assurance team lead, quality assurance engineers and testers including the preparation and delivery of staff performance evaluations and career development activities.Aid Project Director and Project Sponsor on ensuring documentation and processes are being followedProvided training and mentorship to regulatory staff and other staff. Making recommendations for regulatory/compliance departmental operating procedures, cGMP, GMP, GLP and QC Chemistry.Lead safety inspections, European (EU), FDA, CLIA, OSHA and PPTA audits.Performed investigations for Root Cause Analysis, CAPAs, NCRs and deviations.Lead safety inspections, European (EU), FDA, CLIA, OSHA and PPTA audits.Performed investigations for Root Cause Analysis, CAPAs, NCRs and minor deviations.CSL Behring Oct 2006 Oct 2007Compliance ManagerInvestigated, composed, executed, and summarized validation documentation (including but not limited to plans, protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), deviation reports, and root cause analysis reports) in accordance with governing regulations.Interacted with internal and external organizations (i.e. vendors, State and Federal government agencies).Established and supported Computer Validation Teams (CVTs) to oversee and implement the Computer Systems.Lead safety case processing operations and provide site leadership to further develop safety, collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products capabilities.Identified regulatory compliance risks and proactively work with the Business Units, IT, Quality and Regulatory.Titan Corporation (Temporary/Contract) Aug 2003 Oct 2006Medical Technician IIIncluded the tasks of preparing patients for examinations, taking medical histories, demonstrating HIPAA policies, performing phlebotomy, EKGs, and removing sutures.Collected laboratory specimens and sterilize medical instruments. Taking EKG and Phlebotomy samples.Submitted medical claim forms, update patient files, schedule medical tests, and arrange for hospital admissions.AAI Pharmaceutical Jun 2001 Aug 2003Sr. Microbiologist/Scientist IIAseptic and Microbial testing of raw and finished products using USP <71> and <467>, EU, GMP, GLP, cGMP guidelines.Observed, identified, and growing bacteria for pharmaceutical research.Review of batch record for completeness and cGMP documentation.Bayer Corporation Aug 1993 Jun 2001Quality Assurance Laboratory Technician/ISO 9001 AuditorManaged and Developed new formulation and compatibility assays.Strong Analytical and Technical skills in testing pharmaceutical drug products using and troubleshooting several analytical instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Gas Chromatography-Mass Spectrometry (GC-MS), Mass Spectrometry (LC-MS/MS), Inductively Coupled Plasma (ICP), Nuclear Magnetic Resonance (NMR), Total Organic Carbon (TOC), Atomic Absorption (AA), and UV spectrophotometer. Regulations: 21CFR210, 21CFR 211, and ISO 9001.American Red Cross Blood Services Mar 1991 Nov 1999QA Manager/Hospital Services Coordinator/Quarantine TechnicianConsolidated defect tracking and resolution efforts of the User Acceptance Team lead and respective staff,Developed testing activity protocols and developing techniques and standards for use in defect tracking and trending and root cause analysis.Provided regulatory guidance to executive and site management for the development of new products, test methodology, new facility construction, and new manufacturing processes.Developed and directed consistent QA programs within the U.S., cGMP, manufacturing operations, ensuring compliance with cGMP and other pertinent federal and state regulations, international standards and corporate policies.EDUCATION:Bachelor of Science, Biology/ Chemistry, Francis Marion University, Florence, SCAllied Health, Allied College, St. Louis, MOCERTIFICATIONS:American Medical Technology: Certification #102418 |
