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1 - 2 years in Quality performing batch record review and disposition of products at a regulated biotechnology or pharmaceutical company preferred. 1 - 2 years of experience performing batch record review or manufacturing using batch records at a regulated biotechnology or pharmaceutical company.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Norwood, MA client site.
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Understanding cell culture, cryopreservation, purification, aseptic processing or lab technique, Packaging, Shop floor quality, batch review, or disposition preferred. + Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Conduct batch record review for clinical and commercial product manufactured for Humacyte. Under limited direction and supervision, create, review, and revise standard operating procedures.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Lead Technology Transfer activities including: fit-to-plant, process risk analysis, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, and investigation support.
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The Sr. Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots.
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Power electrical engineers will primarily focus on standard industrial systems at the medium voltage (15 kV class) and low voltage ( [Instrumentation & Controls (I&C) electrical engineers will primarily focus on review wiring diagrams, loop diagrams, cabinet assembly drawings, system diagrams, and control logic for both batch and continuous processes using conventional analog instrumentation, distributed digital control systems, and programmable logic controllers (PLCs.
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Keep machine fed with resin mixture by accurately calculating formulation, adding, blending and drying the batch resin components. Start up and shut down equipment including pre-start up safety interlock review.
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Develop departmental goals and ensure the timely completion of all deliverables, including batch record review. The QA AD will also be responsible for overseeing QA activities, ensuring that batch records are reviewed promptly, and that the Quality Management System is effectively implemented, including Quality review and approval of document changes, deviations, change control assessments, and Quality risk management assessments.
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Participates as needed in the development, maintenance, and site compliance of product Quality Plans (QP) (Assembly and/or Molding), Standard Operating Procedures, Inspection Plans (IP), Batch History Record (BHR), Device Master Record (DMR), etc.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Experience with scheduler/workload manager (Portable Batch System (PBS), Simple Linux Utility for Resource Management (SLURM), or IBM Platform Load Sharing Facility (LSF. Review and establish workflow/scheduler policies on HPC systems.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Responsible for batch record review and release of finished products. Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.
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In addition, review and approve CTL assay development and validation reports, relevant sections of clinical documents pertaining to AAV and RNA analytical testing and documentation for submission to regulatory agencies.
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Author/review deviations, SOPs, batch records, CAPAs, OOSs. Routinely execute and review analytical assays for release, in process, and stability in GMP setting. ELISA, HPLC, GMP, Stability Testing, Assay Development, method development, characterization, immunotherapy, assay validation, microbiology, environmental monitoring, cell based assay, potency assay, physico-chemical assays.
ExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The QA Associate I position is an entry level individual responsible for QA functions including daily on the floor activities related to sterile and aseptic manufacturing operations; on the floor batch record review; executed validation review; discrepancy identification; logbook review; AQL inspection of finished product; SAP transactions; room/utility walkthroughs, and product shipping.
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