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Collaborate with cross-functional teams, including the CDMO joint project team, Obsidian Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to assure effective tech transfers and start-up of new manufacturing processes according to agreed upon timelines in support of business objectives.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience with CMMS Systems (SAP, Maximo, Master Control, Blue Mountain, etc.) Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management.
Full-timeExpandApply NowActive JobUpdated 6+ months ago - UpvoteDownvoteShare Job
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The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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He/She will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, Quality Control, Process and Analytical Development and customers to ensure cGMP compliance and establish a quality culture.
ExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Experience working with electronic document systems ( CMMS work orders ,LMS, Track Wise, Master Control ) or similar systems. Support pharmaceutical manufacturing plant, equipment, and utilities, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (cGDP) requirements.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Manage execution of PMP programs consistent with cGMP engineering maintenance requirements. Formal cGMP training. Interact with and direct vendors for manufacturing improvement and plant maintenance (i.e. HVAC, Clean Utilities, trades) primary support for Security/System Monitoring/Fire System, janitorial services, and waste water certifications.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Experienced in ERP transactions regarding cGMP raw materials, inventory control and reporting. Innova Solutions is immediately hiring for a Material HandlerMaterial Handler M-F: 8-5, Overtime available Responsibilities: In this position, you will be responsible for performing and document daily warehouse operations in a cGMP environment.
$32 an hourTemporaryExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc. Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture. The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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This position is responsible for managing the Bedford Site’s Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Experience with DeltaV Process Control System and SAP in a cGMP environment is desirable. Experience with DeltaV Process Control System and SAP in a cGMP environment is desirable. Drives recruiting processes to hire new manufacturing technicians and leads training and development plans of all direct reports.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Quality assurance, Compliance, GMP, Document control, Batch Record, Batch Record Review, product release, investigations, Root cause analysis, iso 13485, audit, quality compliance. Review and approve supplemental logs, charts and other documents in support of cGMP Operations.
$20 - $28 an hourFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Establish overall analytical strategies, including analytical development plans, comparability strategies and analytical control strategies. Early-stage analytical testing (cGMP and non-GMP.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement. Normal responsibilities include detail document control (using Good Manufacturing Practices.
Part-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Experience and Skill Requirements: 10-15 years of cGMP QC testing experience within Bioanalytical/Bioassay/Virology with minimum of 8 – 10 years of personnel management. The Quality Control (QC) Bioassay and Virology Manager is responsible for oversight of the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations (Ops) department in support of our clinical and commercial AAV-based products.
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Oversees outsourced manufacturing, including technology transfer, quality control and product/process development activities for drug candidates from late-stage preclinical development through commercialization.
Full-timeExpandApply NowActive JobUpdated 15 days ago
cgmp control jobs in Bedford, MA
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