- Merck & Co. (Durham, NC)
- …focus and governance to the Durham Site in the following Quality Systems : Change Management, Quality Management System (QMS), and Documentation Management.- ... on both the global and local levels.- As a sub- system owner of these systems for the...experience with Change Management and GMP Documentation Management is required. Electronic document control systems experience is highly… more
- Merck & Co. (Lower Gwynedd, PA)
- …of a variety of automated processing and operational and informational technology systems .Apply deep expertise in the computer system validation process of ... staff while building and maintaining strong working relationships.Serve as a system administrator of equipment applications, temperature monitoring systems , and… more
- Twist BioScience (South San Francisco, CA)
- …Training Specialistwill be responsible for maintenance and sustainment of the eTwist Electronic Document Management System (EDMS) and Learning Management ... related documentsQuality System Metrics monitoring and reportingeTwist system maintenance, as applicableDepartmental projectsSupport other Quality Systems … more
- Merck & Co. (Rahway, NJ)
- …of innovative processes to enable paperless studies through an Electronic Data Capture system .- Stakeholder Collaboration:-Foster cooperative relationships ... manage comprehensive data management processes.Skilled in implementing and optimizing Electronic Data Capture systems .Familiarity with CDISC CDASH/SDTM standards… more
- Merck & Co. (Durham, NC)
- … Systems , Water for Injection (WFI), and Clean Steam (CS)) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), ... operation, maintenance and/or troubleshooting experience with complex process and/or utility systems Experience using electronic manufacturing systems (eg… more
- HEPCO, Inc. (Clinton Township, MI)
- … and contribute to system -level integration. Design and draft electrical/ electronic systems , focusing on wiring harness routing and integration. Develop ... Team (IPT) environment. Required Skills: Minimum of 2 years of experience with electrical/ electronic systems . Expertise in Creo CAD modeling (minimum 2 years),… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU ... assigned by management and continue to develop professionally.Strong proficiency utilizing electronic Quality Systems per curriculum.Utilizes tools within MS… more
- Merck & Co. (Rahway, NJ)
- …pay necessary fees using the United States Patent and Trademark Office's (USPTO) Electronic Filing System (EFS-Web) and/or Patent Center - Proofread granted ... where necessary - Calculate patent term adjustment (PTA) using electronic tools - Monitor the progress of patent applications...named and saved in the IP Group's document management system Review contents of patent application files to check… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents. Electronic Data Capture (EDC) ... Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing… more
- ECLARO (Martha Lake, WA)
- …working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within ... with experience in Laboratory equipment, benchtop instrumentation and Quality System disciplines. The candidate needs to understand shop floor activities,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …final packaging materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved ... individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant and with the...and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …departments.Support Document Management system users with workflow handling and electronic system usage, as needed.Manage the periodic review process for ... environment. This role will ensure compliance within the document management system , document storage and retention, and document issuance and reconciliation.Key… more
- Genmab (Plainsboro, NJ)
- …submission-ready labeling documents; Maintains and tracks labeling documents in the electronic system as appropriate.Participates in the development and ... with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for… more
- Everglades Equipment Group (Loxahatchee, FL)
- …Certification in automotive air-conditioning Read hydraulic schematics and diagnose hydraulic system faults Read electrical schematics and diagnose electronic ... variety of skills from basic mechanical to complex technical diagnostics of modern computerized systems . Must be able to provide own basic tool kit. Must be able to… more
- Merck & Co. (Durham, NC)
- …monitoring during processing and records results in the computerized database system . Provides timely delivery of sample and other materials as required ... EngineeringBioWorks Certificate (working in an FDA regulated industry).Experience utilizing System Applications and Products in a manufacturing setting.Experience in… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist Quality AssuranceSenior Specialist, Quality Systems and Compliance (P3)Our company is expanding its global recombinant vaccine ... and Skills:Strong Batch Record Review and Release experience in electronic systemsPrevious investigation and CAPA experience, Batch Record Review, Validation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to site environmental monitoring program.Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of ... tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as necessary. RequirementsA… more
- Merck & Co. (Durham, NC)
- …start-up testing in new laboratories using principles of our Production Systems , Lean Laboratories, and GMP requirements.- GENERAL PROFILE: Work cross-functionally ... requirements toward analytical testingCapability to function effectively within an automated/ electronic laboratory environment. - BUSINESS EXPERTISE: Understands the fundamental… more
- Aequor (Thousand Oaks, CA)
- …of nonclinical report QC, contribute to data integrity review of electronic lab notebooks (ELN) and assure compliance with operational procedures. Responsibilities ... reflect ELN data sources (traceability to various internal data repositories or systems or source data verification) Coordinate, organize and support the QC process… more
- Aequor (Devers, TX)
- …identify and report any discrepancy from normal practice or procedure. Knowledge of basic electronic systems (email, MS Office, etc.) Attention to detail is key. ... Qualifications HS Diploma required OR enrolled in a scientific program more
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