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Online Resumes with "cfr"
Technical Writer
Thirteen years experience in multiple industries at all organizational levels coordinating technical documentation creation and editing while interfacing with Subject Matter Experts, on-site engineers and technicians, and business partners. Currently seeking challenging opportunity.
Tags for this Online Resume: MS Office, Adobe Framemaker, MS Project, Factory Automation, Laboratory, IQ, OQ, PQ, Validation, Commissioning
Clinical Quality Assurance - 17 Years of Experience - Near 27713
QUALIFICATIONS: QA / Quality Oversight, Data Integrity, Investigations, six sigma, CAPAs, TrackWise, Root Cause Analysis (RCA), Technical / Collaborative / Creative Writing, Microsoft Office, Inhalation, Stability, HPLC, Analytical Analysis, Quality Control (QC), Quality Assurance (QA), Audits, cGMP, cGLP, GxP, cGCP, method development/validation, Instrumentation/Automation, software, 21 CFR Part 11, FDA / ISO / Internation...
Tags for this Online Resume: Quality, Investigations, Regulatory, Writer, Raleigh, Data Review, Biotech, Test, Atlas, Automation, Data Entry, Documentation, Manufacturing, Protocol, Quality Assurance
Industrial Microbiologist
To obtain a Food Safety Scientist position that will utilize my extensive Biomedical/ Pharmaceutical, Food and Manufacturing background and education. Experienced with FDA, EU, GLP, GMP, ISO 9001, HACCP and CFR requirements.
Biological Technician - 15 Years of Experience - Near 94547
Obtain a challenging position to utilize 15 years of experience in the biotechnology industry. Help company achieve optimum operational excellence while producing successful results in lean manufacturing. Increase process efficiency with a focus on safety. Skilled professional to achieve success and increase productivity in a quality controlled safe cGMP environment
Ideal Companies: BioMarin
Tags for this Online Resume: Biotech, cGMP, FDA, AsepticTechnique , ISO, SAP, Quality Control, manufacturing, Compliance, Monitoring
Engineer
QUALIFICATIONS: Technical Skills: * Project management expertise. * Design and implementation of IT networking systems. * Design and instrumentation of electrical control and instrumentation systems. * Design and implementation of SCADA systems. * Six Sigma greenbelt project experience. * Process design and management expertise. * Data analyst capabilities. * CFR documentation for Pipeline and Pharma. * System commissioning...
Tags for this Online Resume: Management, UL, Wonderware, Integration, Project Management, Instrumentation, PLCs, Programming, SCADA
Production Manager - 18 Years of Experience - Near 02725
SUMMARY Eighteen years experience in Manufacturing or Manufacturing support, including over ten years of supervisory experience. Proven ability to drive production against aggressive schedules while rigorously maintaining safety, quality, and regulatory standards. Expertise in training, documentation, and technical transfer functions. Familiarity with Lean Manufacturing and continuous improvement initiatives. Extensive expe...
Tags for this Online Resume: Documentation, Good Manufacturing Practices, Support, Compliance, Housekeeping, Management, Utilities, Evaluate, Kaizen, Lean Manufacturing
Clinical In-house Monitoring - 6 Years of Experience - Near 07621
SUMMARY OF QUALIFICATIONS Pharmaceutical professional with 5+ years of clinical research experience in management and monitoring. Seeking new and exciting opportunities in new therapeutic areas to expand my expertise. Known for building strong relationships with clients and partnering with management teams to ensure quality services, compliance and efficiency. Manage Clinical Research, third party vendors, and clinical inst...
Tags for this Online Resume: Fraud, ICD-9, Insurance, Medical, Query, Management, Good Clinical Practices, ICH, Documentation, Clinical Research
Electromechanical Equipment Assembler - 1 Years of Experience
SUMMARY: * More than 5 years of Experience in cGMP regulated environment. * Manage control of changes, Deviations, OOSIR and CAPA * Review batch records and releases lots * Prepare and revise Standard Operating Procedure for cGMP Equipment * Work both independently and in team to finish project on-time. * Knowledge of FDA regulations and 21 CFR 210 & 211, cGMP/GLP/GDP guidelines for solid and liquid drug products.
Tags for this Online Resume: Manufacturing, Packaging, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Audit, Quality Control
Engineer - 20 Years of Experience - Near 02720
Tags for this Online Resume: CAPA, process validation, process development, root cause investigation, ISO 13485, QSR / FDA CFR Part 820
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Director of Quality - 20 Years of Experience - Near 08810
Summary: Engineering professional with over 30 years of experience in developing, implementing, and managing Quality and Manufacturing management systems. Management experience includes working in small companies to global leaders in metal and plastic industries in diverse manufacturing environments. Working knowledge of ISO 9001, QS 9000, SQF, HACCP, cGMP, FDA (2ICFRPart 110,111,210,211), APQP (Advanced Product Quality Pla...
Tags for this Online Resume: ISO, Manufacturing, Process Control, Quality, Quality Assurance, Audit, Internal audit, ISO 9001, Management, Plastics, SQF, Food Safety, Risk Management, Quality System Implementation, Metal Fabrication, ANSI, ASTM and Mil Standards, FDA, 21 CFR 110,210,210,211, manufacturing, "project management", reliability, production
Not Listed
Experienced with American National Standards Institute (ANSI) regulations for implementation of these plans and for appropriate safeguarding of employees through proper personal protective equipment (PPE) selection. - Identified, procured, and delivered appropriate PPE. - Provided on-site safety and compliance audits for ongoing MTS, LLC projects and concerns. - Provided OSHA-regulated recordkeeping (300 series forms) for a...
Tags for this Online Resume: Compliance, Quality, Quality Assurance, Quality Control, Commercial Construction, Construction, Safety, Radiation, ANSI, oilfield
