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Online Resumes with "bioburden"
Microbiologist - 6 Years of Experience
Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial En...
Tags for this Online Resume: Microbiology, Quality, Quality Assurance, Quality Control, Distribution, Test, Training, Audit, Communication Skills, English Language
Biologist - 19 Years of Experience - Near 27560
Summary: * 15+years of experience in instrumentation and analytical/microbiological testing. * Conducted routine analytical/microbiological testing of raw materials, packaging materials, finished products and environmental samples using approved methods, and established policy * Provided technical support and leadership as pertains to analytical/microbiological testing: verify that results are accurate and complete, recogni...
Tags for this Online Resume: ISO, Management, High Performance Liquid Chromatography (HPLC), Max, Model Driven Architecture, Scheduling, ELISA, Instrumentation, Assessments, Audit
Microbiologist - 9 Years of Experience - Near 28704
To become a member of a quality driven team Over 9 years in Quality Assurance/control, 3+ years in a supervisory position of multi-functional teams with up to 16 direct reports within the microbiology lab. Experienced in team building, protocol design and execution, CAPA investigations, Environmental monitoring, endotoxin screening and bioburden.
Tags for this Online Resume: Manufacturing, Plating, Quality, Quality Assurance, Quality Control, Spectrophotometer, ISO, SAS, Microbiology, Internet, protocol, sas, pharmaceutical, environmental monitoring, supervisor
Experienced Lab Associate
Tags for this Online Resume: ELISA, Chemistry, Documentation, Manufacturing, Quality, Quality Assurance, Quality Control, compendial, raw materials, final products, GC, HPLC, Bioburden, DSC, OOS, SOP
Production Supervisor - 0 Years of Experience
HIGHLIGHTS OF QUALIFICATIONS 1. Many years of pharmaceutical leadership experience in a Biotech and parenteral drug-manufacturing environment. 2. Diversified experience in sterile manufacturing including bulk manufacturing, aseptic filling, component sterilization, freeze drying, environmental monitoring, inspection and packaging. 3. Knowledge of governmental cGMP, OSHA, DEA regulations and procedures, experience with FDA, ...
Tags for this Online Resume: Packaging, Inventory, Manufacturing, High Performance Liquid Chromatography (HPLC), Leadership, Monitoring, pH Meter, Spectrophotometer, Labor Relations, Occupational Safety and Health Act
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Keeping Options Open
Tags for this Online Resume: Excel, Filing, Bioburdens, LAL, Archiving
Microbiologist - 0 Years of Experience
* University of California Santa Barbara, CA. on the Nomination of the faculty: * Graduated Dean's Honors Fall 1994, Bachelor's Degree majoring in Biochemistry-Molecular Biology * American Society for Quality: (recertifications pending as required) o "ASQ" Certified Quality Engineer 5/23/2010: Certification No. 55743 2013 o "ASQ" Certified Quality Auditor 6/5/2010: Certification No. 40845 2013 o Aseptic Processes/Steriliza...
Tags for this Online Resume: Manufacturing, Utilities, Quality Assurance, Instrumentation, Management, Packaging, Commodities, Compaq Alpha, Documentation, Procurement
