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The tutor for BioWork should have overall competency in the following topics:Biotechnology/BioManufacturing/Biopharma Industry PracticesWorking SafelyPharmaceutical Quality Current Good Manufacturing Practices (cGMP)Standard Operating Procedures (SOP)Measurements, Metrics, and MathChemistry for Process ManufacturingProcess Flows, Technology, and EquipmentControlling the Process and Maintaining QualityCleanroom Gowning and Aseptic ProcessingFermentation and Cell Growth.
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The Plant Sanitation Technician will also be required to follow through on established daily cleaning requirements for the overall cleanliness of the facility to ensure adherence to Good Manufacturing Practices (GMP), Safe Quality Food (SQF) standards, Pasteurized Milk Ordinance (PMO) and internal product quality standards.
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The Sr. Manager will be responsible for leading all facets of Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP.
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To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
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Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Candidates please note : Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply.
ExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Experience 3 years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production. Previous experience with Laboratory IT systems such as LIMs, LES, and MODA. Additional Preferences: Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
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This position requires a BS/BA in Virology, Cell Biology, Microbiology, Biochemistry, or related Science, with 5 years working in GMP virology lab or related experience. As a Supervisor of QC Virology, a typical day might include the following: Supervise the contract lab testing program for cell bank and unprocessed bulk (including the cGMP aspect.
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The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc. The auditor must have strong QMS/GMP Auditing experience having conducted many Supplier or External audits throughout his or her career.
$1,000 - $1,300Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A minimum of 3 years’ experience in a GMP manufacturing environment with a bachelor’s degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field or seven years of experience in a clinical quality assurance environment.
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The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GLP, GCP, GVP and GMP functions. Collaborates with internal functions and aligns goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices.
$315,000 - $320,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The Quality Manager (PC) will ensure that all Quality related functions are compliant with GMP regulations and consistent with company policies and procedures in addition to conducting audits that insure continuous control over materials, facilities and products throughout the production cycle.
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5+ years of GMP Quality experience with focus on cGMP compliance and product quality for US and EU. Drug Substance. 5+ years of GMP Quality experience with focus on cGMP compliance and product quality for US and EU. Drug Substance.
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Familiarity with GMP/cGMP documentation and the project change cycle process. Proficiency in creating VMs or Disk Images, data collection, inventory control, hardware disposal, and data archival.
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A proven record of technical problem-solving experience with standard operating procedures and cGMP analytical testing; most tasks will be non-GMP. Need someone to start ASAP. 100% onsite lab based role at Rahway,NJ.
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Develops and provides annual GMP/GDP training content (e.g., consistent training plans for new hire GMP/GDP training, on-the-job training, compliance, etc.) Working knowledge of industry guidelines including cGMP, regulatory guidelines (i.e.: FDA, EU, ICH, ISO), and handling of regulatory inspections.
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