- Merck & Co. (Rahway, NJ)
- …in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates ... on issues related to protocol conduct,-recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections-and overall site performance.Identifies, assesses and… more
- Merck & Co. (Rahway, NJ)
- …management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO ... Job DescriptionDevice Development Associate Principal Scientist - Device Engineering and Early...image consisting of a delivery device component/constituent (ie, predesign control ). This will include directing development and assessment in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …reliance on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC ... support GMP clinical production. -Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and IT… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …discharge compliance. Develops and improves site policies, prepares and submits regulatory reports, independently track recurring regulatory reports & permitting ... referral: 0 Essential Functions Environmental & Waste Management Prepare and submit regulatory reports and filings, to include: air emissions, Tier II, Toxics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... who interact with PMRT in accordance with the AOP; maintain training documentsQuality Control of all PMRP Material Access review material through the PMVP Confirm… more
- American Honda Motor Co Inc (Marysville, OH)
- …professional experienceDetailed knowledge in the following areas is necessary: internal control , risk assessment and mitigation, legal / regulatory ... AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest quality and… more
- Merck & Co. (Durham, NC)
- …have the safest and most compliant operation around the network.EMSS has an Associate Director opening for the Teknika maintenance and Engineering team. The selected ... environment with optimized product quality and manufacturing processes and regulatory compliance. GENERAL PROFILE Provides leadership and direction through… more
- Merck & Co. (Durham, NC)
- …and approval of system commissioning and qualification documents, change control , automation incidents, Quality Notifications (QNs), and other key automation-related ... processesProviding direct support for regulatory inspections and audits and other validation activities by...Technical organizations to resolve complex problems. Responsible for Fermentation control Systems specific to areas of Seed and Production… more
- Aequor (Melville, LA)
- …- 6&plus months contract - Onsite roleResponsibilitiesThe QC Stability/Lab Technician Associate is responsible for assisting with the company's stability program for ... stability program and to support the QC Laboratories with sample receipt/ control and glassware maintenance.For the stability department, this includes the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …report contains the technical merit and completeness according to regulatory expectations. The Deviation Investigator-Writer will be responsible for initiating ... ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Operations and Quality teams Lead… more
- Merck & Co. (Durham, NC)
- …maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and preventative maintenance ... handling unit maintenance, operations, and reliability)Automated systems (eg, Distributed Control System, Programmable Logic Controllers)Maintenance equipment (eg, tools, calibration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Catalent (Harman, WV)
- …limited to, purchasing, sourcing, logistics, warehousing, inventory management and control , material forecasting, functional capacity planning and sourcing, S&OP ... recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to procurement.Develop and continuously… more
- Novo Nordisk Inc. (Boulder, CO)
- …and associate raw materials if applicable. Experience in quality control , analytical method, transfer, and qualification in a GDP/GLP environment with hands ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, ... for selected candidate.Relationships Reports to: Director of MSAT & Quality Control Number of subordinates with direct/indirect referral: Incumbent will have mix… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role is eligible for relocation assistance. Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: none, this is ... ongoing supervision and development opportunities Support the submission of worldwide regulatory filings Performs all job duties and responsibilities in a compliant… more
- Sunrise Systems Inc (Seattle, WA)
- …Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document ... Job Description: Top Skills: 2+ years of Document Control & Reporting Experience, Veeva experience preferred Technical troubleshooting Self-motivated, independent,… more
- Integrated Resources, Inc (Bothell, WA)
- …procedures, edits, and annotations within EDMS experience The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document ... during the audit. * Assist with document retrieval /organization support during regulatory inspections. * Perform Document Control metric reporting and analysis… more
- Integrated Resources, Inc (Mounds View, MN)
- Job Title: Associate Medical Writer Job Location: Mounds View, MN Job Duration: 24 Months Job Description HM's Top 3: . Detail-oriented. . Quick learner . Strong ... of complaints/adverse events from literature to GCH. . Perform quality control check, compilation, formatting, and tabulation on clinical evaluation documents, as… more
