- Daiichi Sankyo, Inc. (Bernards, NJ)
- …procedures, risk impact assessment mitigation procedures, to maintain audit readiness, data integrity , security, consistency and transparency across programs. ... business and our partners for end-to-end improved quality, consistency, security and integrity for all studies. Establish log/traceability of data access… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Data implementation, quality initiatives, and reporting as well as ensuring Master data integrity and standards are applied to all related processes and ... Data Governance Program Responsible for definition, control, quality, integrity and policy compliance regarding the Master Data... integrity and policy compliance regarding the Master Data Domain Works closely with Sr. Manager - … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process improvements and other initiatives. Proactively identifies and manages risks to data quality, data integrity , programming and reporting deliverables, ... and in-house operating models. Is accountable for the quality, integrity , and timely delivery of all external data in line with the established data transfer… more
- Merck & Co. (Rahway, NJ)
- …reference and nomenclature data into a centralized databasePerforming data integrity review activities, including proofreadingDeveloping rules to ensure ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and data protection. Ensures accuracy and completeness of supplied engineering data . Establishes and maintains integrity controls Provides the means, methods ... The Position This position is responsible for the ownership of the Engineering Data Management System (EDMS) while collaborating with the Engineering team to provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SOPs, specifications and other applicable acceptance criteria.Responsible for managing data integrity via software controls (Deskman, Windows, etc).Executes, ... quality assurance, or manufacturing compliance.Thorough knowledge and understanding of GMP data integrity standards.Knowledge of cGMP regulations and FDA/EU… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the development of data governance policies and practices to ensure data integrity and security Utilize BI tools and programming languages Utilize tools ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Tris Pharma (Monmouth Junction, NJ)
- …with business successful implementation and operations of all IT applicationsOversees data integrity , security and protection of information assets including ... aligned with company goals. Incumbent oversees all IT projects, IT operations, Data Privacy and overall Information Security, and also is responsible for managing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …closely with QA functional teams to align and promote awareness on data integrity and good documentation practicesFacilitate and Coordinate with Project ... and CAPA logsReview of specific in-process, and finished product data such as eLims samples data , MES calculations, EBR completeness, SAP data , and… more
- BioAgilytix (Durham, NC)
- …to compensationOversee the implementation, maintenance, and optimization of HRIS systemsEnsure data integrity , security, and accuracy within the HRISGenerate ... regional needs. The Director will ensure HRIS systems operate seamlessly, drive data -driven improvements, and stay ahead of global and local industry best practices.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …risk management decisions are done in a disciplined manner to document decisions and rationale. Data Integrity - ensure GMP data captured and managed by ... the FDA and other regulatory agency audits. Serve as an Internal Auditor. Data Management- perform statistical data analysis and prepare reports.pFMEA- facilitate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP regulations and FDA/EU guidance related ... controls system software, hardware and associated interfaces inclusive of data management, issues, deviations, corrections, remediation and improvementConducts local… more
- Aequor (Newbury Park, CA)
- …plans, ensuring transportation compliance, providing supply chain reporting, and maintaining master data integrity using 's planning and execution systems. Key ... Supply chain reporting to Tax and Treasury departments - Global Master Data reporting - Working Cell Bank inventory reportingBasic Qualifications: '-High school/GED… more
- Novo Nordisk Inc. (Durham, NC)
- …Support training planning and development of technicians and analysts Review lab generated data to ensure data integrity and timely reporting for ... batch release as needed Facilitate problem solving, investigations, and process improvements Responsible for ensuring laboratory areas are inspection ready Responsible for supervising their team to include performance management, coaching, development,… more
- Merck & Co. (Rahway, NJ)
- …overseeing the development and maintenance of clinical databases and ensuring the integrity , consistency, and confidentiality of data collected during laboratory ... Checks:-Develop and execute comprehensive edit checks to maintain the integrity and consistency of data .- Discrepancy Management:-Collaborate with Clinical… more
- Merck & Co. (Rahway, NJ)
- …Subject Matter Expert,Conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as ... the quality lead for the oversight platform,Supporting product development teams in outsourcing activities to enable our diverse pipelineServing as the bridge for quality oversight between research and development and commercialization… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP) Assist with ... executing responsibilities associated with preparing for the production of aseptic or terminally sterilized product (compounding, filling, sterilization, palletizing, transfer), and/or accurate and timely completion of associated production paperwork Assist… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP) Support Supplier ... Quality Team with coordination of area projects and continuous improvement initiatives Ensure timely completion and accuracy of procedural documents related to Supplier Audits, Supplier Complaints, Supplier Qualifications, and Supplier Requalification's… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …(SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)Oversee/execute the ... set-up, operations, troubleshooting/resolution of equipment Complete line clearance/changeover activities for finishing productionPrevent product/label mix-upsGuide the finishing team to perform responsibilities associated with inspection, packaging, labeling,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Procedures (SOPs), batch records, current Good Manufacturing Practices (cGMP), including Data Integrity and Good Documentation Practices (GDocP)Assist with ... performing set-up, operations, and basic troubleshooting of equipment Participate in line clearance/changeover activities for finishing productionAssist with preventing product/label mix-upsPerform activities to support the inspection, packaging, labeling,… more
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