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Company: Actalent
Location: Arcadia
Posted on: March 11, 2023

Job Description:

Description: building of the QC Microbiology laboratory from ground up for a Cell and Gene therapy biotech startup. lead method transfer and validation studies commission new equipment author and edit Quality system procedures, lead continuous improvement initiatives, represent QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports. Drive change controls, lead investigations, CAPAs, and continuous improvement initiatives to successful completion. Lead in performing validation of microbiological assays and provide training related to in-process and drug substance testing, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion testing, etc. Skills: Clean room, microbiology, environmental monitoring, capa, validation, bioburden, quality control, growth promotion testin, endotoxin, change control, method transfer Top Skills Details: Clean room,microbiology,environmental monitoring,capa,validation,bioburden,quality control,growth promotion testin,endotoxin,change control,method transfer Additional Skills & Qualifications: Degree in Microbiology (can accept bio sciences) 4+ Years of Microbiology Experience (must be in pharma or biotech - needs clean room, GMP mfg experience required) Must have experience with Validation, Change Control, CAPA's, Environmental Monitoring, Bioburden Testing, Processing Samples of Water, Endotoxin Testing, Growth Promotion tested in-process and/or drug substances to detect bioburden? tested in-process and/or drug substances for the presence of endotoxin? method validations? (describe in detail what method validations they have performed in the QC Microbiology lab) Experience Level: Intermediate Level About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Arcadia , Microbiologist, Other , Arcadia, California

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