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Online Resumes with "Batch records"
Production Supervisor - 20 Years of Experience - Near 08505
PROFILE * Team leader with 21 years of experience in the pharmaceutical manufacturing and R&D product development industry. * Thoroughly dependable, loyal and well organized, detail oriented and mechanically inclined able to take the lead to get the job done. * Proficient and knowledgeable of industry standards, SOP's, GMP's and their practical applications. * Utilizing strong, constructive communication to train and lead t...
Tags for this Online Resume: Manufacturing, Pharmaceutical, Packaging, Compliance, production, reliability, manufacturing
Industrial Qualification Engineer - 20 Years of Experience - Near 35758
Accomplish engineering manager with extensive qualification/validation experience in the FDA regulated industries including electronic batch records. Skilled in process development optimization and design of experiments. Extensive hands on operating knowledge from design basis through commercial manufacturing in the solid dosage parenteral biotechnology bulk chemical and medical devices fields. Career experience in US Mexic...
Tags for this Online Resume: Packaging, ISO, Utilities, Complaints, Management, Compliance, Manufacturing, Assessments, Endoscopy, Audit, hvac controls, lonworks, test
Quality Manager - 16 Years of Experience - Near 00693
Profile Excellent team work and versatile person with a Bachelor Degree in Science and over ten years of experience in the Pharmaceutical, Diagnostic and Biotechnology industry, including: Quality Assurance (QA) and Manufacturing. Able to administrate computer systems, identifies and evaluate compliance issues. Experience with start-up Projects in the quality and manufacturing areas. Proven leadership capabilities coordinat...
Tags for this Online Resume: Quality, Manufacturing, Quality Assurance, Product Release, Audit Process, Batch Record Review, Test, Diagnostics, Inventory, Media Preparation
Clinical Quality Assurance - 8 Years of Experience - Near 93036
SUMMARY: Goal oriented, Science driven, quality professional with a strong academic background in Cell & Molecular Biology with applications in Biotechnology and Bioinformatics. I am a skilled communicator that has served in various health care positions, supplementing graduate course work with field experience to exercise effective judgment and critical thinking.
Tags for this Online Resume: QA, Audits, GMP, FDA, Quality, Compliance, ELISA, Manufacturing, Therapy, Cancer, oncology, pharmaceutical, Batch Record, Immunotherapy, Drug product, Drug substance
Biological Technician - 2 Years of Experience - Near 03079
CAREER HIGHLIGHTS * 10+ years hands-on experience as a leader in a highly innovative bio-pharmaceutical, cell-culture Manufacturing Corporation working in small scale and large scale upstream manufacturing (Inoculum prep to 15K bioreactors, harvest processes and media compounding). * Supervisor for 7 to 10 associates in a fast-paced environment with high-throughput customer requirements. *Mitigate production anomalies by li...
Tags for this Online Resume: Management, Pharmaceutical, Documentation, Manufacturing, pharmaceutical, biotechnology, supervisor, Assessments, quality assurance, specialist
Biological Technician - 20 Years of Experience - Near 21703
SUMMARY: Supervisory professional in the biotechnical field. Broad knowledge in manufacturing and production. Particular expertise in: *Installation, Performance, and Operational Qualifications *Fermentor Operating and Maintenance *Writing SOP's and Batch Records *Validation
Tags for this Online Resume: Install, Utilities, Support, Technical Support, Valves, Research, Training, Cardiopulmonary resuscitation (CPR), Dec, First Aid
Clinical Quality Assurance - 15 Years of Experience - Near 03811
Tags for this Online Resume: Complaints, Documentation, Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, Risk Analysis, Test, Compliance, Kaizen, trackwise, batch record review, CAPA, deviations, audit, VEEVA
Chemist - 20 Years of Experience - Near 84341
Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...
Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface
Clinical Quality Assurance - 20 Years of Experience - Near 46360
Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...
Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance
Production Supervisor - 20 Years of Experience - Near 00674
SUMMARY OF QUALIFICATIONS Professional with degrees in Master in Business Administration and Bachelors in Biology and Accounting. Over twenty (20) years of experience supervising processing operations in the pharmaceutical / manufacturing industry. Well experienced in electronics Batch Records Authoring, Rockwell Systems (PMX). Proven attributes in visionary and innovative thinking leading to practical applications in the d...
Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, SAP, Electronics, Automation, Training, Complaints, Corrective Actions, Documentation, manufacturing, "project management", production, maintenance
Biochemist - 18 Years of Experience - Near 44202
Professional Summary I have over ten years of experience in the Biotech industry in both Research and Development and Quality Control). Accomplishments/Skills Technical experiences skills including: * Protein purification using anion exchange, affinity, HIC and SEC as well as HPLC. * Operation of an Agilent and Water's HPLC * Operation of the GE AKTA and Bio-Rad NGC FPLC systems * Cloning and expressing proteins in E. coli....
Tags for this Online Resume: Process Improvement, Troubleshooting, High Performance Liquid Chromatography (HPLC), Quality Control, Research, Manufacturing, Protein Purification, Protein Analysis, ELISA Assay, Western Blot analysis, qPCR/PCR, Cloning, cGMP
Machine Operator
COVER LETTER: Dear Hiring Manager, With response to your advertisement in Monster.Com, I am applying for the post of Manufacturing Technician Chemist in your organization, I am in the biopharmaceutical manufacturing industry for more than thirteen years now and I have exceptional technical knowledge. I am confident that my candidacy will surely exceed your expectations. As a team lead and OJT trainer, I have handled many im...
Tags for this Online Resume: 5S, Corrective Actions, Manufacturing, Pharmaceutical Industry, Root Cause Analysis, Team Lead, Troubleshooting
