- Merck & Co. (Rahway, NJ)
- Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role will ... and quality in line with industry best practices. Education: Bachelor's degree in computer science, Engineering, or a related field, systems analysis, or a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to...validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process validation , computer system validation and ... and subject matter experts to prepare for FDA and other agency auditsEnsure site/ system validation program meets FDA, ISO and EU requirementsCollaborate with… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control, Client interface, Lab… more
- Catalent (St. Petersburg, FL)
- …Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems ; b) process improvement projects and Product Development ... QA Product Manager Position SummaryThe QA Product Manager ...has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& understanding of change control processes Expert understanding of validation / system development life cycle approach Basic computer skills including ... eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering… more
- Eisai, Inc (Nutley, NJ)
- …vendors, and consulting companies); Managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies. ... Architects and IT Operations. Partner with ITQA, Business Owner and IT Project Manager for defining a master validation strategy where applicable. Partner with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and Abilities: Strong working knowledge of facility related systems including Clean Water Systems , Clean Steam System , HVAC Systems , and Compressed Gas ... Systems Ability to read and understand sophisticated architectural, equipment and system drawings Computer literate Proven Team player Previous experience in… more
- Novo Nordisk Inc. (Durham, NC)
- …approval of validation activities associated with minor changes to existing systems . Performs archiving duties & QA presence & process confirmation on shop ... floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with...Understanding of the Batch Review Processes required Understanding of validation preferred Understanding of quality management systems … more
- Aequor (Seattle, WA)
- …of manufacturing quality (manufacturing, packaging, facilities, critical systems , validation , etc.). Must complete tasks independently, notify manager of ... skills with MS Office (eg Word, Adobe, Visio and Excel) and with Quality Systems (eg Document Management System , Quality Management System ) Must demonstrate… more
- Colorado Housing and Finance Authority (CO)
- …for Single Family loans daily. Performs assignments out of Mortgage Electronic Registration System (MERS) on all loans in a delinquency and bankruptcy status and ... provides backup to MERS system . Monitor the advance and repayment of funds advanced...there are any issues. This individual reports to the Manager of Servicing and Post Closing. essential functions *… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …incident escalation and follow-up beyond the organization, Tier 4) Analyze complex computer systems , identify problems, and develop and implement logical ... IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems : Drive...including close interaction with other local SMEs in IT/OT, System Managers, and IT QA Maintain IT services and… more
- Sunrise Systems Inc (Summit, NJ)
- …with the ALCOA+ principles of data integrity, risk-based approaches to validation , Computer Software Assurance (CSA) principles Understanding the concept ... Systems Familiar with the development of CSV documentation ( Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT],… more
- Bering Straits Native Corporation (Jamestown, ND)
- …James town, North Dakota.The Lab is under construction. The Project Engineer Lab Manager will participate in the certification and validation through the ... Corporation is currently seeking a qualified project Engineer Data Manager for the United State Army Corp of Engineers,...computer screens and requires extensive use of a computer , keyboard, mouse, and multi-line telephone system .… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …hire).Educational Requirements: Bachelors degree , preferably in a related field ( Computer Science, Business Analytics, Management Information Systems , Data ... Technology Work Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is rooted in a foundation of improving the...health of our communities. About the Role:Job Summary The Manager - Reporting & Self Service manages a team… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …equivalent) in Analytics, Data Science, Advanced Computer Science, Computer Science, Engineering, Information Technology, Information Systems , Mathematics, ... equivalent) in Analytics, Data Science, Advanced Computer Science, Computer Science, Engineering, Information Technology, Information Systems , Mathematics,… more
- OSI Group (Chicago, IL)
- The Assistant QA Manager will serve as a liaison between key customers and OSI in supporting complaint investigation, in-restaurant product assessment, product ... validations; and managing Distribution Center complaints, projects, and credit system .Provide technical and customer relationship support to the customer's… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …to enhance scale by developing reusable components and capabilities.Observes the current system in operation and gathers and analyzes information about each of the ... s degree (or foreign education equivalent) in Data Science, Computer Science, Computational Statistics, Operations Research, Engineering, Information Technology,… more
- Sunrise Systems Inc (Seattle, WA)
- …of manufacturing quality (manufacturing, packaging, facilities, critical systems , validation , etc.). Must complete tasks independently, notify manager of ... skills with MS Office (eg Word, Adobe, Visio and Excel) and with Quality Systems (eg Document Management System , Quality Management System ) Must demonstrate… more
- Russell Tobin & Associates (San Diego, CA)
- …clinical trials execution in a GCP regulated environment Support Drug Safety Pharmacovigilance, Computer System Validation and GLP Work closely with internal ... we looking for in our R&D Quality Risk Management Manager ? The Scientific Team at Russell Tobin & Associates...Experience in R&D Quality Risk Management or R&D QA systems and Health Authority regulations Experience with drug development… more
