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Online Resumes with "21CFR"
Department Manager - 20 Years of Experience - Near 00693
Professional validation expert and scientist with up to thirty years of overall experience in the Pharmaceutical Medical Device and Biotechnology Industry. Proficient in manufacturing industry environment including but not limited to facilities utilities solid dosage equipment HVAC water systems chemical plant equipment chemical biotechnology and microbiology instrumentation handling validation (IQ OQ PQ) validation plans c...
Tags for this Online Resume: Quality, Quality Assurance, Project Leader, Project Management, Support, Manufacturing, Test, High Performance Liquid Chromatography (HPLC), Injection Molding, Instrumentation
Quality Engineer
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: Packaging, Manufacturing, Documentation, Management, Quality, Quality Assurance, Quality Management, Test, Quality Control, Training
Project Manager - 20 Years of Experience - Near 60124
Skills Summary A Senior Software Professional who has exceptional project management, client relationship and leadership skills with a proven track record of managing multiple projects with multiple stakeholders and multi-disciplinary teams delivering projects on time, on budget and to the client's satisfaction. * A certified PMP having 20+ years of Software Engineering experience that includes: * Project Management and Sta...
Tags for this Online Resume: Project Management, Project Manager, Management, Oncology, ISO, Pharmaceutical, CFR Part 11, Documentation, Change Management, Insurance
SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS
Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer
Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive
Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult
Clinical Research Project Manager Interested in Growing with a Patient Centered Organization
My career goal is to first obtain a clinical research project manager position with an innovative, patient-centered pharmaceutical company, medical device company, clinical research organization (CRO), or medical center. Eventually, I would like to prepare to segue into international development as a Senior Director and play an integral role in developing a research infrastructure for new companies and/or those interested ...
Ideal Companies: Pfizer, AstraZeneca, Becton Dickinson, etc.
Head of Quality looking to refocus
I am applying for an upper management position within the Quality Department. • Experienced research and development. A scientist who successfully transferred knowledge, skills and experience in industry for new product development and processes in Pharmaceuticals and Nutritional Supplements. • More than fifteen years of managerial experience, which includes functioning with both domestic and global cross-cultural gr...
Tags for this Online Resume: Complaints, Documentation, Audit, Inventory, ISO, Manufacturing, Procurement, Quality, Quality Assurance, Quality Control
Quality Manager
SUMMARY 40 years of experience in Quality Assurance/Quality Control, with 30+ years in Quality Management. Working knowledge and ability in multiple environments: Class (7) 10,000 and Class (8) 100,000 Clean Room Construction, Operation, and Control. Medical Component and Device Manufacturing with Test and Assembly, Aerospace Supplier Development, Including all aspects of AS9100 requirements and AS9102 documentation. Multi-...
Tags for this Online Resume: Management, Medical, Aerospace, Automotive, Electronics, Packaging, Quality Assurance, Test, Clean Room, CNC
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology
Supply Chain Manager - 0 Years of Experience
Accomplishments across the Tenure ~ Efficiently revamped 5S LEAN and effectively led operations through ISO 13485 certification process ~ Proficiently minimized temporary workforce by 80%, enhance picking accuracy by 50%+, and develop delivery time by 12% even with the addition of 10-20 daily stops ~ Successfully secured 0 OSHA recordable accidents through the reduction of safety incidents by 31% ~ Planned, designed and imp...
Tags for this Online Resume: Distribution, Filing, Green Belt, Pharmaceutical Industry, Retail, Training, Quality, Quality Assurance, Inventory, Management
Clinical Regional Monitoring - 21 Years of Experience - Near 60031
Over 15 years experience in Clinical Research and Regulatory Study Protocol specifics - ICF's, Inclusion/ Exclusion Criteria, AE/SAE, eCRF's, and SOP Development/Updates * Exceptional attention to detail with strong problem solving skills * Excellent written, verbal and decision making skills * Outstanding interpersonal communication, organization and prioritization skills * Proficient with GCP, ICH guidelines, FDA regulat...
Tags for this Online Resume: Program Manager, Collection, Accenture FOUNDATION, Accounts Payable, Attention to Detail, Billing, Biomedical Industry, Budgeting, Clinical Research, Data Mining
Mechanical Drafter - 20 Years of Experience - Near 94509
Mechanical Draftsman/Designer with 20+ years experience in high-volume, rapidly changing environments. Extensive expertise in mechanical/electrical assembly drawings, bills of materials, electronic and mechanical component specifications. Possess rare background in both electronics and mechanical drafting, including schematics and work in printed circuit board layouts (bare boards and assemblies). Expert in Windchill PLM, ...
Tags for this Online Resume: Adf (App Dev Tool), CAD Tools, Electronics, Document Control, Engineering, Engineering Drawings, Enterprise Requirements Planning, Enterprise Resource Planning, Management, Planning
Quality Manager - 20 Years of Experience - Near 75216
Proven Scientist/Chemist with experience in oilfield services and chemical manufacturing. Specialty areas include Quality Assurance Laboratory and Oilfield Service Company Laboratory Management with emphasis on oilfield chemicals, design and testing of cementing, completion fluids, and teaching employee groups. Responsible for accurate Certificates of Conformance and Certificates of Assurance for all in-coming raw material...
Tags for this Online Resume: Manufacturing, Chemistry, Good Laboratory Practices, Good Manufacturing Practices, ISO, ISO 9001, Management, Publications, QA/QC, Quality Assurance
