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Online Resumes with "21CFR"
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Quality Engineer - 14 Years of Experience - Near 91016
 Over14 years of in-depth experience in the pharmaceutical industry.  Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.  Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Medical Scientist - 14 Years of Experience - Near 30269
I'm a Bilingual, Army –Trained Medical Professional with pharmaceutical experience to include GxP, quality control immunoassay testing, environmental monitoring, laboratory investigations, and exception reporting. My Army Service includes 10 years experience in Clinical and Research applications of microbiology, phlebotomy, hematology, resource management, safety, risk assessment and mitigation, process improvement and emp...
Tags for this Online Resume: GMP, GDP, GLP, MP, Quality Conol , Pharmaceutical, 21 CFR 211, Non Conformance reporting, CAPA, Quality Control Associate, Root Cause Investigations, Scientist, Microbiology, Environmental Monitoring, Assessments, Audit, ELISA, Quality, Quality Assurance, Quality Control, Research, Test
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume: CAPA, FDA, ISO, Complaints, Auditor
Project Manager - 10 Years of Experience - Near 07901
Ms. Marilynn Goldsmith is a PMI certified Project Manager. Her experience includes projects in integrated oil, insurance, and pharmaceutical sectors. She has been responsible for the project schedule, categorization and management of issues, risks, change and quality management of project deliverables including managing 21 CFR Part 11 Validation and the associated deliverables. 
Tags for this Online Resume: SDLC, Offshore Teams, MS Office, Deliverable , Validation, Quality, Team Mgmt, Issue/Risk, Management, Oracle, Database, Documentation, Oracle Database, PWC, Requirements Definition, SEC
Senior Process Validation Lead
Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.
Manager - 13 Years of Experience - Near 46037
Sr. Manager with 5 years’ experience managing individual contributors and supervisors in a global environment Proven Quality Assurance leadership skills to ensure IT/Lab/Site compliance with internal procedures and regulatory requirements Demonstrated ability to successfully lead continuous improvement initiatives with effective planning and organization skills • Lead CAPA Investigations • Host FDA/CAP/DOH/Client Audits ...
Tags for this Online Resume: CAPA, 21 CFR Part 11, SDLC, Metrics, FDA, Quality, Validation
Quality Assurance Auditor - 12 years Experience - Pharmaceuticals
Quality Assurance Auditor with proficient skills and experiences in various compliance disciplines. Have a passion to conduct local, international, and global audits, training, and provide guidance services within the following regulatory specialties: â?¢Good Laboratory Practices (GLP) 21 CFR Part 58 â?¢Good Clinical Practices (GCP), VICH GL9, Document 85 â?¢Environmental Protection Agency GLP (EPA-GLP), 40 Code of Federa...
Tags for this Online Resume: Auditor, GLP, GCP, Quality Assurance, QA Manager, QA Auditor
Business Analyst - 14 Years of Experience - Near 60031
System Analyst with significant progressive experience in the IT operations of a world class highly regulated health care company. Possesses solid working background and expertise in programming languages, software development and validation activities, systems database and analysis, operating systems, evaluation of business needs and computer platforms and systems, development and deployment of IT solutions, testing and de...
Tags for this Online Resume: .Net, PL/SQL, Crystal report, C, MS Office, Visio, HP Quality Center
Biomedical Engineer - 20 Years of Experience - Near 94025
Key start-up contributor. Extensive knowledge of medical device development and manufacturing. Experienced with distilling physician interactions into new product ideas, assessing new tech/Market, Feasibility and Prototypes. Tenacious, out of the box thinker. Willingness to pitch in to both critical and mundane projects necessary to the company. Visionary innovator/manager with extensive experience in medical products acro...
Tags for this Online Resume: Product Development, ISO13485 21CFR820, Medical Devices, V, Prototyping, Research , Process Development, Commercial release
Product Complaints Specialist
Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills
Ideal Companies: Biomedical, Biotechnology, Healthcare compliance
Tags for this Online Resume: compliance, Regulatory
Operations Manager - 18 Years of Experience - Near 97013
Dynamic, results oriented Medical Device Manufacturing Operations Executive who has demonstrated the ability to lead diverse cross-functional teams to new levels of success in medical device manufacturing. Strong analytical, technical and business qualifications with an impressive track record of more than 16 years of hands-on experience in strategic planning, business unit development, project and product management, and s...
Tags for this Online Resume: FDA, ISO 13485, 21 CFR 820, cGMP, Medical Device, Manufacturing, Operations, Production, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP, Development Activities, Documentation, Medical, Medical Devices, Sourcing, Enterprise Requirements Planning, NCR, SAP
