- Novo Nordisk Inc. (Plainsboro, NJ)
- …and managing four functional areas: Policies & Training, Monitoring & Auditing, Investigations , Technology & Data Analytics. This leader plays a critical part in ... for Policies & Training, Monitoring and Auditing, Technology and Data Analytics, and Investigations (four direct reports). May serve as a member of global ethics &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …your potential? The Position Strategically manages assigned litigation and investigation matters (commercial, contract, employment, antitrust, False Claims Act, ... product liability, consumer protection, pharmaceutical pricing, personal injury), government investigations , product complaints, and risk mitigation/reporting for Novo Nordisk… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evaluating external compliance trends, internal business strategies, monitoring, auditing, investigations data, and compliance controls to proactively advise the ... healthcare practitioners and regarding compliance obligations, risks, violations, resolution, investigations , and corrective actions Communicates planned business activities to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and duties of personnel within the quality department.Perform manufacturing investigations , writing investigation reports, and facilitating corrective and ... preventive actions including:Provide management oversight for quality control, batch records, and material review board.Provide management oversight for all QMS documents and change control. Ensure adherence to procedures.Collaborate with department heads to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … investigations into product/process failures, wiring concise and thorough investigation reports into root causes, and evaluate potential preventative measures ... The ability to manage multiple projects, priorities, and people in a fast-paced environmentEducation Experience and Other Requirements: A Juris Doctor from an institution accredited by the American Bar Association;Five (5) or more years of experience as a… more
- Merck & Co. (Rahway, NJ)
- …technology transfer to internal and external manufacturing sites, manufacturing investigations , process validation, and authoring of regulatory submissions. -Under ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Merck & Co. (Millsboro, DE)
- …and/or works independently as a team member on technical investigations , validation and/or process improvement projects.Examines issues from diverse perspectives ... evaluations.--Creates and updates technical and manufacturing documents necessary for investigations , process design/definition, engineering studies, process demonstrations, change control… more
- Merck & Co. (Durham, NC)
- …transfer/qualification reports, standard operating procedures, change controls, and investigations for the performance of laboratory methodsInitiates and contributes ... to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative ActionsExecute test method… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment to complete tasks required to meet business objectives.Support Investigations team by providing quality and compliance input for continuous ... Collaborate with (cross)functional departments to resolve issues related to batch review/release, investigations , and receipt of QC test results to allow for timely… more
- Merck & Co. (Durham, NC)
- …Manufacturing Practices (GMPs), safety, and environmental regulations.- Participates in investigations of automation incidents and problems to prevent recurrence ... including the development and implementation of corrective actions. Over time, become a subject matter expert (SME) in specific process steps, automation technology platforms, and specific systems. Over time, becomes expert practitioner of structured problem… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the root cause and corrective actions for problems associated with investigations Completes accurate and timely assessments associated with change control activities ... Ensures change control activities for systems are completed in a manner in compliance with FDA, EU and NN regulations Responsible for the verification of new and existing equipment, processes and instrumentation as needed Write and review protocols, summary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the Policy, Training and Communications team and the Monitoring and Investigations teams. This includes writing and research assignments under the direction of ... various Compliance functions as well as working on special projects for each of the Compliance Department functions. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Aequor (Swiftwater, MN)
- …with some administrative work. Follow company safety procedures and compliances. Lead investigations to resolve problems and to identify root causes. Will be ... required to work with glass and stainless steel reactors and be comfortable with manual labor. Familiarity with ascetic techniques is a must, familiarity with bioreactors is a plus. Meet project requirements and timelines.Basic Qualifications: Work experience… more
- Merck & Co. (Durham, NC)
- …technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methodsTrouble-shoot laboratory process ... and equipment issues as neededSample managementPlanning and test method execution to meet established delivery timelinesProvide active support during audits and inspections (regulatory, internal, safety)Assist regulatory groups by providing documentation to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train operators on processes and QMS ... systems. Relationships Reports to: According to the organizational chart Number of subordinates with direct/indirect referral: n/a Essential Functions Liaison between Production Support and Manufacturing for the coordination of process/equipment improvements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Indepth data mining secondary business analysis: Conducts hypothesis-driven investigations into detailed physician-level, patient-level and transactional-level data, ... to gain business insights from various customer perspectives (HCPs, patients, payers) independently or with collaboration with other analytics teams Develops innovative solutions to unstructured, complex problems; recommendations have significant impact on… more
- Merck & Co. (Rahway, NJ)
- …experience Demonstrated problem solving ability including the ability to perform investigations with strong technical troubleshooting skills and to assist in ... developing/implementing CAPAs- Experience with common analytical techniques such as chromatography, spectroscopy, and Karl Fischer Strong communication (verbal and written) and interpersonal skills Ability to quickly adapt to changes and develop appropriate… more
- Merck & Co. (Rahway, NJ)
- …Practices (cGMPs), and participating in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).- Position Qualifications :Education ... Minimum Requirement: The position requires a BS or higher in Chemical Engineering from an accredited college/universityPosition Requirements / Required Experience and Skills:Strong understanding of chemistry and/or chemical engineering fundamental… more
- Merck & Co. (Durham, NC)
- …methodsTrouble-shoots equipment issues as neededInitiates and contributes to laboratory investigations as needed and follows site procedures in the documentation ... of Quality Notifications and Preventative ActionsCollaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirementsProvides active support during audits and inspections (regulatory, internal, safety)Supports our Manufacturing… more
- Merck & Co. (Rahway, NJ)
- …proactive assessment of the product robustness, rapid response to complex investigations and emerging regulatory expectations, and enterprise leadership of technical ... priorities in support of the value chain.Horizon analyses of emerging technologies to trigger our Manufacturing Division's capability build at right time to ensure readiness to support our future pipeline.Create a strategic and agile portfolio management to… more
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