- Merck & Co. (Rahway, NJ)
- …processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that ... Job DescriptionThe Associate Director, ESQL is responsible for all activities...Control including solid knowledge of global GMP and regulatory requirements. ORMaster of Science (MS) degree in Science,… more
- Merck & Co. (Rahway, NJ)
- …enhancements, next generation process development, and authoring of regulatory submissions.Under the general scientific and administrative department direction ... Represents functional area on cross-functional and cross-divisional teams.Authors required regulatory and technical documentation.- Ensures that processes are developed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of ... strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has… more
- Merck & Co. (Rahway, NJ)
- …(include Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation will ... in a state of permanent inspection readiness.Serving as Quality SME during regulatory inspections and audits.Education Minimum Requirements BS or MS degree 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
- Insmed Incorporated (Bridgewater, NJ)
- …quality systems, validation principles, engineering design, and statistical process control fundamentals.Experience with providing technical authoring of CMC drug ... substance sections of regulatory filings and dossiers.Sound awareness of Regulatory , Quality Assurance, and cGMP requirementsHigh energy, innovative "can do"… 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
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... Must be able to read electrical prints, P&ID's and understand P&ID control loops. Extensive industrial experience involving utility systems with a strong knowledge… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Accountable for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... compression stills, compressed gas systems) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)- Clean-In-Place… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... reverse osmosis skids, vapor compression stills).Automated systems (eg, distributed control system, programmable logic controllers).Maintenance equipment (eg, tools and… 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
- 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
- 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. (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. (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
