- 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
- Cytiva (Pensacola, FL)
- …within life sciences, diagnostics and biotechnology?At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared ... belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at… more
- Cepheid (Miami, FL)
- …behind every test there is a patient waiting.Learn about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is ... plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing continuous and rigorous assessment to identify and implement… 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)
- …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)
- …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)
- …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
- 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
- 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
- Pall (Miami, FL)
- …life sciences, diagnostics and biotechnology?At Pall Corporation, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared ... belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …diagnostics and biotechnology?At Beckman Coulter Life Sciences, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared ... belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at… 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. (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
- 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
- Pall (Miami, FL)
- …life sciences, diagnostics and biotechnology?At Pall Corporation, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared ... belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at… 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
- Beckman Coulter Diagnostics (Miami, FL)
- …sciences, diagnostics and biotechnology?At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a ... and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into...one million tests are run on Beckman Coulter Diagnostics systems , impacting 1.2 billion patients and more than three… 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
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