- Aequor (Athens, GA)
- …document management systems . Must be able to follow precise computer system instructions with high attention to detail and minimal oversight. Must balance ... Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems . Electronic Document… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...approval of standard operating procedures and any other required documentation .Collaborate with functional departments to resolve issues.Perform tasks in… more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide expertise ... qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment,… more
- Repligen (Hopkinton, IA)
- …is responsible to actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the document control department in ... processing documentation requests. They will work closely with cross-functional teams...to meet established deadlines (paper and electronic).Maintains related database systems , if applicable, logs and complete forms/records as required.Adheres… more
- Merck & Co. (Rahway, NJ)
- …manufacture and/or regulatory inspections. Independently performs audits of batch documentation , data, information, procedures, equipment and systems , and/or ... Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture,… more
- Twist BioScience (South San Francisco, CA)
- …perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe...define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data… more
- Merck & Co. (Rahway, NJ)
- …activities.- Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP ... GMP and developmental use.- Author, review and approve GMP procedures and documentation , with an emphasis on Qualification and Validation plans around equipment,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Merck & Co. (Rahway, NJ)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... of tools within our Company's ecosystem and with upstream/downstream systems .Apply industry standards and ontologies to develop FAIR (Findable, Accessible,… more
- Merck & Co. (Rahway, NJ)
- …packages to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such ... as master inventory lists, qualification documentation , calibration documentation , computer system inventories Support internal and external quality audits… more
- Merck & Co. (Durham, NC)
- …production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Aequor (Thousand Oaks, CA)
- …plates. Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy. Job Summary ... sample requirements against SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will work in a team… more
- Eisai, Inc (Nutley, NJ)
- …eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined timelinesPerforms eTMF internal reviews, ... detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COLProvides general enrollment figures to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... authoring, review and approval of new or updated procedural documentation . In addition, this role will work closely with...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- AUROBINDO (Durham, NC)
- …staff members and management on policies, as well as providing documentation .Assist with policy administration including managing leave of absence requests, FMLA, ... and producing reports, as needed. (currently utilizing Paylocity as our HRIS system )Assist in talent acquisition and recruitment processes by creating and posting… more
- Eisai, Inc (Raleigh, NC)
- …with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation , and reporting of quality goals ... with procedures to support timely product lot disposition.Maintain associated documentation and records electronically in accordance with internal standards.Support… more
- Eisai, Inc (Exton, PA)
- …pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to ... validation protocols and reports, and SOPs, along with providing supporting documentation . They formulate the overall strategy for Upstream and Downstream Operations… more
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