- 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
- 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
- Merck & Co. (Rahway, NJ)
- …, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: Monitor ... (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements and processes pertaining to system management for… 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- 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. (Austin, TX)
- …role-you will help design and deliver the next generation of cybersecurity systems through secure, intelligent automation. You will build workflows that integrate ... function focused on transforming how cybersecurity operates-less detection, more design. The systems you build will be foundational to how we scale AI, automate… 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
- Twist BioScience (South San Francisco, CA)
- …and convert them into Salesforce features and configurations. Create detailed documentation including business process flows, user stories, solution designs, and ... admins, and third-party vendors.Guide integration between Salesforce and other enterprise systems (eg, ERP, Order Management Systems , external data… more
- Aequor (Athens, GA)
- …in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation ... enrichment materials. Maintains, adjusts, and repairs animal pens, feeders, drinking systems , and livestock handling equipment. Performs cleaning and sanitation of… 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
- 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
