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Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc. Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
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The Scientist is responsible for instrument validation/repair/maintenance from user side, reagents management, performing cell based assay and impurity assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus. Ensures compliance with cGMP and safety requirements. Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus.
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Thorough knowledge of cGMP, ICH guidelines, current USP policy and methodology, FDA guidelines and inspection requirements, and industry guidance in the areas of pharmaceutical microbiology.
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Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage-specific cGMP manufacturing. Knowledge and compliance to cGMP, FDA, Data Integrity, and other biopharmaceutical regulatory requirements preferred.
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Requirements High school diploma with at least 1 to 2 years process operations experience A.A.S. or B.S. degree is preferred. System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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Recording and investigating quality events within process compliance and performing in-process sampling, Quality Control Chemistry, and Quality Control Microbiology. Reviewing, revising, and completing batch records using Logbooks, and SOPs in accordance with cGMP standards and aligned with written procedure.
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Quality control, Microbiology, laboratory, Quality assurance, Gmp, Biology, Environmental monitoring, Cell culture, fda, titration, sop, pcr, cgmp, batch record, qc. Quality control, Microbiology, laboratory.
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Perform duties associated with aseptic processes, weighing, measuring, counting, calculations, sampling, and verifications required for biological production processes in accordance with batch production records (BPR) and in compliance with current good manufacturing practice (cGMP) standards, all current safety standards and site procedures.
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Minimum four (4) years of experience in the biopharmaceutical industry within a cGMP Quality Control role Experience with cell and/or gene therapy products is a plus. Fundamental knowledge of Quality Control operational and laboratory practices including, but not limited to, microbiology, analytical testing, sample management, quality records, and training.
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Additionally, the Microbiology Manager is a key customer-facing role which requires outstanding technical knowledge, project management and execution skills, and a passion for helping customers achieve their objectives.
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Manufacturing technician, quality control, biology, cell culture, mammalian cell culture, Gmp, Microbiology. The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites.
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Laboratory, Biology, Quality control, biology, chemistry, quality, qc, qa, quality control, quality assurance, lab tech, lab*, fda, haccp, gmp, cgmp, usda, sqf, brc, aib, gfsi, Microbiology.
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Qualifications: Skills: •Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology). Responsibilities include the following activities: product release, quality system, compliance, document management, and any related activities needed under current Good Manufacturing Practice (cGMP.
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The QC Microbiology Specialist, Lentivirus Vector (LVV) CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the LVV facility to support clinical trials and commercial operations in a controlled GMP environment.
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