Experienced Quality Manager with a proven record of developing the methodologies and tools to help companies manage organizational change, meet customer requirements and provide product excellence. Has extensive project team and department management experience in Quality Management and Regulatory Engineering, primarily for information systems, telecommunications and medical applications. Highly analytical, dynamic, resul...
Ideal Companies: Juniper, Tellabs, Sonus, Sycamore, Wyeth, Phillips, Siemans
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Program and Project Management, Business Analysis/Process and Data Analyst, Software Quality Assurance (SQA),, Requirements Management, Configuration Management, Defect Management, Quality Systems Development and Quality Management, Business Process Vision and Policies, Organizational Development and Re-engineering, Business Systems Requirements Specification, Course Development and Technical Training, Process and Training Documentation and Technical Writing, Product Design and Qualifications (power and packaging), Component Engineering (analog and materials), European and Asia Pacific business experience, Data Base Development and SQA, Use Case Modeling, Requirements and Defect Management, Issue Management, Document Management, KPI Definition, Analysis and Business Process Improvement, Use Cases Development, Test and Training, Internal Audit Planning, Implementation and Management, Hardware and Software PLC Management, Software Development Life Cycle (SDLC), Product Safety, EMC, EMI Environmental Management, Manufacturing, Customer and Field Support, Standards and Regulatory: UL, CSA, IEC, ISO, VDE, BSI, KEMA, FCC, FDA, PTT, BABT, OSHA, NEC, Sarbanes-Oxley (SarbOx/SOX), COBIT, Standards Making Committees: ECMA TC12, CBEMA ESC2, TIA, Process Frameworks: ISO 9000:2000 and TL 9000 (cGMP/QS9000 equivalent), CMMI, ITIL, SWBoK, PMBoK, RUP, and Sarbanes-Oxley compliance, Mass Quality Award/Baldridge Evaluation/Implementation, ODI and Rummler-Brache Process Improvement Methods, Metrics and Tools: TQM, SPC, TL9000 and GR-929 metrics implementations and Six Sigma tools and methodologies
To obtain a position in the Quality discipline where my skills and background will be utilized to make substantial quality improvement contributions.
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Validation, Quality Control, MS Office, cGMP , Quality Assurance, ISO 9000
Position in Quality Assurance in a biotech facility. Included document review and archiving, change control, auditing, developing and implementing programs in the Quality System.
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cGMP, audit, regulatory, compliance, ICH, quality
A Research Scientist with extensive experience in formulation and process development as well analytical expertise bringing projects from prototype to pilot scale up through commercial launch, including tech transfer activities. Hands on experience in developing and technical problem solving skills. Excellent team member, flexible in rapidly changing environments. Knowledge of, cGLP, cGMP, EPA, DEA and FDA Regulatory guidel...
Use my experiences in safety, auditing, training, pharmaceutical, cGMP and more to work with a company and their employees in overall improvment of their processes and goals.
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Manager, Auditor, Safety, cGMP, Trainer
I am looking for an organization that values its employees. I am ready for a challenging position within a pharmaceutical/biotech industry
Ideal Companies: Imclone, Merck, Shering-Plough, LifeCell, Integra, Actavis
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Experienced, Quality, CAPA, Tech Writer, GMP, FDA, manufacturing, leader, Microsoft Suite, CQA, Six Sigma, Lean Manufacturing, Quality Assurance, inspection, process excellence, bilingual, BA, Masters
Highly motivated, personable, detail-orientated Analytical Chemist with extensive knowledge in LC/MS/MS bioanalytical analysis, method development, validation, and transfer methods. Working experience in development and validation of analytical procedures in pharmaceutical, agrochemical, and personal care product in cGMP/cGLP environment. Strong organizational and communicational skills and experiences as part of a multidi...
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HPLC, LC/MS/MS, QC, Dissolution, UV-VIS, Bioanalysis
I am trying this out and I amt rying to figure out how to do this
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cGMP, HPLC, Lyophilization, facilities
As a research scientist I would bring my knowledge in GMP analytical testing, method development, validation, technology transfer and project management to the growth and development of your organization. I am experienced in cGMP regulations, laboratory investigations, inspections and global regulatory filings. Furthermore, I am a self-motivated, diligent, conscientious and dependable chemist with excellent analytical, co...
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Chemist, Senior Scientist, Method Development, Method Validation, Auditor, Writer
