- BioAgilytix (San Diego, CA)
- …operating procedures (SOPs) including those for account management, systems configuration, change control, and incident handlingAdditional ResponsibilitiesAt all ... less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System … 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...activities, as needed.Support drafting, review and approval of standard operating procedures and any other required documentation.Collaborate with functional… more
- Merck & Co. (Rahway, NJ)
- …is responsible for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC ... systems comply with regulatory standards (eg, FDA, cGMP), maintain...analytics.Establish and monitor key performance indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis… more
- Merck & Co. (Rahway, NJ)
- …performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating ... regulatory, etc. at all levels. Establish, educate, and enforce standard operating procedures (SOPs) required under GMP. Develop/update SOPs to ensure practices… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Aequor (Athens, GA)
- …and compressed air. Conduct regular inspections and preventative maintenance to ensure systems are operating efficiently and safely. Engage in technical ... team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in...past experience, as well as documented SOPs and Detailed Operating Procedures (DOPs) are needed as resources to resolve… more
- Merck & Co. (Rahway, NJ)
- …enable better business decisions.-Through analysis of equipment history, process data, operating procedures and Failure Modes Effect Analysis and many other data ... through statistical techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop and-maintain-Site… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Rahway, NJ)
- …accordance with US and WW regulations, company policies and Standard Operating Procedures.The Associate Director, Business Insights and Analytics (BI&A), is ... solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data warehousing more… 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
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and replenishment. This individual will also work with inventory management systems and execute cycle count and reconciliation activities to ensure inventory ... and internal clients. This individual will need to train and follow standard operating procedures and work instructions and comply with cGMP regulations and safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of processes and programs Leverages knowledge of topics such as networking, operating systems , application architecture, cloud, log management, SIEM, SOAR, case ... of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this… more
- Aequor (Athens, GA)
- …Research and Teaching, BI AH policies and Veterinary Sciences standard operating procedures, and the fundamental requirements for AAALAC accreditation. In addition, ... enrichment materials. Maintains, adjusts, and repairs animal pens, feeders, drinking systems , and livestock handling equipment. Performs cleaning and sanitation of… more
- Novo Nordisk Inc. (Durham, NC)
- …in methods, techniques, approaches, etc. required Proven expertise in Windows based operating systems and associated applications required Proven expertise in ... self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, MES, SAP, PI Historian)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Repligen (Hopkinton, IA)
- …basic and complex assembly techniques, executing detailed visual inspections, operating manual and automated machinery, and completing packaging and labeling ... met.ResponsibilitiesConduct basic assembly techniquesRead manufacturing drawings and follow standard operating procedures of varying complexityPerform detailed visual inspections on… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... including audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the COE Develop and leverages relationships with HQ SMEs, process management, and system management to influence process and system development in a manner ... as it relates to PV through understanding of NN Standard Operating Procedures (SOPs) Advanced knowledge and participation on internal audit/inspection readiness… more
