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Online Resumes with "regulated environment"



Quality Assurance Specialist - 12 Years of Experience - Near 03079

SUMMARY OF EXPERIENCE * Software testing specialist with 12+ years of experience working within computer software industries. * Six years directly related experience as software Quality Engineer in a regulated environment and thorough understanding of QSR/MDR/eMDR requirements and FDA expectations related to software validation of ERP, PLM, QMS applications and systems * Strong domain knowledge on Health Care, Pharmacy, Ret...

Tags for this Online Resume: Applications, Database, Extensible Markup Language (XML), IBM, IBM DB2, IBM DB2 Database, Java Programming Language, Management, Microsoft SQL Server, Regression Testing, validation

Manager - 20 Years of Experience - Near 01867

Career Summary Insightful, results-driven information technology cybersecurity professional with notable success in directing and managing a broad range of Information Security initiatives while analyzing, planning, developing and implementing solutions in support of technical and business objectives. Excels in the implementation of comprehensive Information/Cybersecurity programs, while managing, motivating and guiding tea...

Tags for this Online Resume: Disaster Recovery, Management, Planning, Risk Management, Documentation, Training, Information Security, Infrastructure, Security, Support

Clinical Quality Assurance - 10 Years of Experience - Near 19454

SUMMARY My work as a Quality Assurance professional has afforded me the luxury of possessing vast workplace skills. Notable career expertise includes, but is not limited to an ability to assess manufacturing conditions, spot potential nonconformances and take preventative/ corrective actions, utilizing Lean Implementation Methodologies. I have been conditioned to assure US/EU/FDA regulations in pharmaceutical, non/clinical,...

Tags for this Online Resume: Quality Assurance, Test, Manufacturing, Audit, Compliance, Consulting, Documentation, Management, Metrics, Packaging

Project Manager

SUMMARY Experienced IT Software professional specialized in working with clients to understand and implement requirements and applications/systems to provide business analytics and strategic solutions in various roles as a Senior Business Analyst, Senior Project Manager, Senior SFDC Architect, Senior Program Manager/Product Manager and Senior Product Owner. Collaborate with product management, engineering and other cross-fu...

Ideal Companies: program mgnt

Tags for this Online Resume: Inventory, Support, Active Server Pages, Forecast, Forecasting, Oracle, Quality, Quality Assurance, Data Entry, Planning

Quality Assurance Specialist - 14 Years of Experience - Near 34685

Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...

Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall

General Manager - 18 Years of Experience - Near 18013

Summary of Qualifications Results-oriented, high-energy, hands-on professional, with a successful record of accomplishments in nearly twenty years in the retail industry. Was given the opportunity to open a new store from the ground up. Responsibilities included setting shelves, stocking shelves, setting store to planogram, securing vendor contacts, and merchandising. Recruited, selected, hired, trained entire new staff. Tr...

Tags for this Online Resume: Human Resources, Inventory, Merchandising, Accounts Payable, Billing, Complaints, Deposits, Financial, Financial Reporting, Management, store manager

Quality Manager - 16 Years of Experience - Near 30038

SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...

Tags for this Online Resume: Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans

Microbiologist - 8 Years of Experience - Near 00681

Efficient professional with 9 years of experience in biotechnology industry. Two (2) years of competent experience in validations field. Seven (7) years of successful experience in manufacturing floor with vast expertise in cell culture inoculation processes and media preparation. Experienced on equipment preparation for manufacturing process. Abilities on successful troubleshooting with outstanding results. Able to work un...

Tags for this Online Resume: Automation, Biomedical Industry, Data General Nova, Documentation, Manufacturing, Media Preparation, Packaging, SAP, Troubleshooting, Business Plan, phase, protocol, pharmaceutical, team leader, Trainer, goals achievement, Cell Culture, Upstream

Accountant - 19 Years of Experience - Near 30331

Professional Summary Financial Accountant specializing in financial planning, reporting and analysis in both private and public sectors.Skilled Tax Accountant with the strong work ethic and sense of ownership needed to excel in a government-regulated environment.Capable Accountant successful at managing multiple projects and consistently meeting deadlines under pressure. Extensive knowledge of accounting software and proces...

Tags for this Online Resume: Accounting, Accounting Software, Audit, Financial, Financial Statements, Payroll, Reconciliations, Software, Probate, Billing, accounting, finance, tax, accountant, audit

Operations Manager - 20 Years of Experience - Near 32779

Summary Industrial Engineering professional with 27 years of experience in different manufacturing environments as Food industry as Food Process Engineer, Medical Devices, as QA staff Engineer, and Software & Clean Molding as Director of Optical Media Mfg. Exposed to regulated environments, new technology, Customer relations, Products transfers, Process start ups. Had work from many different areas as engineering, quality, ...

Tags for this Online Resume: Manufacturing, Process Improvement, Test, Engineering, Quality, Quality Assurance, Training, Planning, Scheduling, Integrate, manufacturing, "project management"

Medical Equipment Repairer - 20 Years of Experience - Near 35124

Professional Summary Facilities and Maintenance Operations professional with a progressive career history and proven track record of excellence in the biomedical and educational industries. Experienced in developing programs and procedures to ensure cost-effectiveness and compliance in highly-regulated environments. A strong leader with experience managing and supervising teams of 20+. Detail-oriented and self-motivated to ...

Tags for this Online Resume: Biomedical Industry, Cms, Compliance, Documentation, Engineering, Inventory, Security, Transportation, Life Safety, Management, healthcare, Facilities, Biomedical Eng

Project Manager - 19 Years of Experience - Near 92113

SUMMARY OF QUALIFICATIONS: Results-oriented, high-energy, hands-on professional, with a successful record of accomplishments in the management field. Experience in quality assurance and customer service with focus on providing the highest quality of service. Major strengths include strong leadership, outstanding communication skills, high level of competency, great team player, attention to detail, dutiful respect for compl...

Tags for this Online Resume: Networking, Wireless, Data Backup, Internet, Compliance, Information Technology, Training, Accounting, Administrative Tasks, Attention to Detail, Management