- Merck & Co. (North Wales, PA)
- …Web Data Specialist is responsible for the day to day content preparation , delivery, processing, troubleshooting and publishing to all digital versions of The ... in all languages.The specialist is the primary steward of the content management system (CMS) maintaining The company's Manual content in proper XML structure and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process. Support the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports, issue audit observations ... to support monitoring of key performance indicators; support the preparation of compliance data for the monthly CRB &...monthly CRB & quarterly QSMR presentations. Fulfills the Quality System audit module site key user responsibilities - represent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal controls ... and accounting policies. Optimizes Financial Disbursement technology through system upgrades and other proven automation practices to build efficiencies and stay… more
- Merck & Co. (Durham, NC)
- …of Quality oversight for drug product, drug substance, media preparation , and sterile supply.Position Responsibilities:Reporting to the Quality Assurance ... compliance with cGMP, regulations, and our Company's Quality Management System .Supporting areas such as Design, Commissioning, Qualification and Compliance covering… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …adequate systems and process support; ensure timely and effective preparation and management of HA inspections, including facilitation of respective regulatory ... as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory inspection… more
- Aequor (San Diego, CA)
- …high-throughput purification capabilities using Lynx900 and KingFisher Flex System .Packing of chromatography columns, operating endotoxin free chromatography, ... including operating preparative (FPLC) and analytical (HPLC) chromatography systems .Analytical characterization including endotoxin measurements, protein quantitation assays, analytical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …work orders and projects to ensure proper working order and compliance of systems with cGMP's. Assists with preparation of yearly Facilities budget, audit ... working knowledge of facility related systems including Clean Water Systems , Clean Steam System , HVAC Systems , and Compressed Gas Systems Ability… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of Brownfield projects including: installations, modifications, and ugrades to existing systems & equipment. This position can be considered for Commissioning ... Essential Functions Maintains proficiency and understanding of Facilities, Utilities, Systems and equipment operations Author and participate to complete… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Institutional Review Board (IRB) and other regulatory agencies to include: preparation and maintenance of regulatory binder information and all IRB correspondence ... charts, prepares source documents, and related duties. Organizes data for the preparation of project progress reporting and for proposals for new funding.Contributes… more
- Catalent (Philadelphia, PA)
- … System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. Other ... function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory… more
- Merck & Co. (Rahway, NJ)
- …provide input on perspective discipline.As a Company representative, supports the preparation process of the grievance procedure.- Attends grievance hearings as a ... to maintenance and repairs.Utilize electronic technologies; electronic work order systems , e-training, and email. Position Qualifications :Education Minimum Requirement:… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …start-up, verification and validation activities of new equipment and systems . Responsibilities include verification protocol execution (FAT, SAT, DQ, Commissioning, ... IQ, OQ, & PQ), data analysis and final report preparation Participate in the development and implementation of procedural...well as the continued operation of such facilities Ensures systems and processes are verified and validated in a… more
- Eisai, Inc (NJ)
- …have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions ... improving medical writing capabilities within own area by improving systems / tools and providing trainingMonitoring and evaluating project metrics, escalating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming ... and maintenance- Evaluate, assess and enhance DSI computing environment system . Responsibilities include: continue assessing DSI new computing environment … more
- Merck & Co. (Rahway, NJ)
- …studies (eg, medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials). - Support development of Protocol and ... will partner with CSSM team members to train on systems and tools to complete tasks and deliverables critical...of the ICH3 guidelines. Develop an understanding of the systems and tools critical to the oversight and conduct… more
- Shimadzu Scientific Instruments (Houston, TX)
- …of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Ground-breaking scientific research, manufacturing ideas ... REQUIREMENTS: CASUAL WORKING THOROUGH Human Relations Skills Corporate Structure/EnvironmentReport Preparation Chemistry Customer Relations Skills Telemarketing Knowledge Experience with… more
- Shimadzu Scientific Instruments (New York, NY)
- …of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Ground-breaking scientific research, manufacturing ideas ... Skills Inventory Knowledge Analytical Instrumentation Customer Relations Skills Report Preparation PROBLEM SOLVING REQUIREMENTS: Incumbent should be proficient at… more
- Shimadzu Scientific Instruments (Washington, DC)
- …of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Ground-breaking scientific research, manufacturing ideas ... expert for the MS products. (Daily) Must be capable of independent preparation of samples, sample analysis and interpretation of results, and report generation.… more
- Aequor (Athens, GA)
- …receipt (including the maintenance of the log book, coolers and freezers), preparation of retention samples, maintenance and discarding of retention samples and ... are consistent and within regulatory requirements. Functional knowledge of computer systems such as laboratory information management systems (LIMS) is required.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs. ... development and implementation.Supports packaging design and patient kit supply preparation , label generations and approvals and associated interactions with… more
