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Online Resumes with "Manufacturing deviation"
MS Office Database Design, Development and Implementation including help and training - 15 years
Utilize my database and interface design skills to create user-friendly database applications using software that's already on most users' desktops, Microsoft Office. Update legacy apps to the new MS Office format. Include in-line help and training to smooth the transition to the new application.
Tags for this Online Resume: relational database design, user friendly, built to user specifications, upgrade legacy apps, VB/VBA, training and implementation
Quality Engineer - 20 Years of Experience - Near 55379
Accomplished Staff Quality Control with broad expertise from a clinical setting to the biomedical manufacturing environment. Adaptable and thrives on new challenges and opportunities. Experienced in working independently and with multi-disciplinary teams. Communicates well internally and externally to solve problems. Strives to find new ways to streamline processes.
Tags for this Online Resume: Manufacturing, Quality Control, CAPA, Document change control, Molecular and immunology testing, Manufacturing deviation, Data analysis/review, Shakopee
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
Biochemist/Quality Manager
I am looking for a challenging position of increasing responsibility in Quality or Research and Development. Trained Biochemist/Molecular Biologist with over 22 years of experience, including 15 years of extensive research and drug development experience in Hematology/Oncology. This includes a diverse set of laboratory techniques and administrative skills. I have had positions of increased responsibility and I was a co...
Ideal Companies: Abbott, Medtronics, Boston Scientific
Tags for this Online Resume: Beta Testing, Filing, Quality Assurance, Audit, research scientist hematology
