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Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs.
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Develop services for data processing (ETL/ELT) catering to both batch and real-time data engineering requirements. Develop services for integrating a variety of data sources into Everest’s Data Lake, supporting both batch and real-time data.
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Performs technical review of batch filling records to ensure quality of aseptic processes. Experience with WFI sampling (water for injection sampling) "water testing" Experience with Veeva Vault a plus Experience with Autoclave expected Comfortable with traveling between their two sites in South Plainfield and Piscataway (will be compensated for travel) Benefits 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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This position requires technical expertise in AKTA purification skids or similar, TFF and knowledge of initiating batch records, protocols, investigations and other technical documents. Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
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Coordinate the conduction of investigations and corrections for issues found during the batch execution process. Job Type Full-timeDescriptionJob TypeFull-timeDescriptionThe Downstream Manufacturing Supervisor is a hands-on position responsible for executing purification of mammalian cell-based cultures and producing recombinant proteins for a wide range of mammalian based biosimilars.
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Issue, assembly and review of documentation supporting batch, laboratory, warehouse, metrology, engineering and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements.
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Design, optimize, and troubleshoot cell culture processes in batch, fed-batch, and perfusion bioreactor systems. Design, optimize, and troubleshoot cell culture processes in batch, fed-batch, and perfusion bioreactor systems.
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Perform API/ Filler calculations as required per Batch Card. Ability to follow Batch Card and proper documentation practices. Performs re-determination for batch cards. Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
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5+ years of software engineering experience working with Java frameworks including Spring, Spring Batch, and Spring Boot Hibernate, etc. 5+ years of software engineering experience working with Java frameworks including Spring, Spring Batch, and Spring Boot Hibernate, etc.
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Complete pick functions encompassing all pick processes: Paper Pick, Paper Smart Pick, Paperless Pick, Parcel Batch Pick, LTL Pick. At TD SYNNEX, we're proud to be recognized as a great place to work and a leader in the promotion and practice of diversity, equity and inclusion.
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Provide clear, accurate, documentation of each phase of production process on batch card. Responsibilities Ensure compliance with cGMP, Quality Systems Regulations, WIs, SOPs, and Health & Safety Requirements.
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Provide technical leadership to ensure integrity, quality, and security of core platforms that include custom developed web application, web portals, back-end batch processes and MS Dynamics CRM solution.
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Perform job duties that require constant attention to manufacturing and batch record process. Ø Verify labels with batch manufacturing records. Completion of batch records. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests.
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Prepare batch sheets and manage technical input to batch records and other quality documents according to ICH and FDA guidelines. Train GMP personnel on batch record writing and GMP related SOPs.
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Around here, every day starts with a fresh batch of bread and a thousand possibilities. You love baking, even if you're a beginner. Bake all the fresh bread and pastries your cafe needs each day.
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batch job in Edison, NJ
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