- Legend Biotech USA, Inc. (Raritan, NJ)
- …sterility, growth promotion, as well as other microbiological assays.Utilize electronic systems (LIMS) for execution, documentation, review of testing.Perform ... in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe… more
- Aequor (Libertyville, IL)
- Business Systems Analyst12 Months Contract with possible extensionLocation:Libertyville, IL - 100% Onsite Top Skills:Expert in SAP S4/Hana, specifically EWMAdept in ... science experience preferred Overview:The SAP S4/Hana Business Delivery Lead Systems Analyst is a service-oriented, positive, forward-thinking team member… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document Management system users with workflow handling and electronic system usage, as needed.Manage the periodic review process for procedures, ... This role will ensure compliance within the document management system , document storage and retention, and document issuance and...to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director, Device System - Design Control plays a pivotal role in combination product development (both design and process), commercialization and ... and post market surveillance. Key Responsibilities and Activities: The Director, Device System - Design Control will expand and manage a team that are… more
- Merck & Co. (Millsboro, DE)
- …training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC), ... regulations, and corporate/site policies including safety and biosafety.Utilize our systems such as Reliance, Atlas SRM, WorkDay, myLearning, eTime, Inspire.Compose,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Payroll-HR processes and data to ensure correct and efficient integration of Payroll-HR systems .- Keep current on Payroll-HR system trends with a working ... with keys partners in other Departments, and maintaining the payroll and PTO/time systems . This individual must have acute attention to detail, ability to multitask… more
- Aequor (Bothell, WA)
- …Performs review of validation documentation, periodic reviews of validated systems , and/or procedures, as assigned. Responsibilities 1. Compile and perform lot ... review 2. Apply the principles of good quality systems and GMP, as assigned on a daily basis...validation plans, protocols, data, and reports in controlled document system ; Must be able to organize information in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health ... regulatory submissions and / or inspections Ensures that appropriate systems , processes are in place to enhance GLP/GCLP activities...with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and is responsible for the ongoing production support of Commercial and R&D IT systems and applications. The individual in this role owns the support of technical ... in the R&D space including but not limited to clinical trial management system , drug labeling, and learning management system .Administration of enterprise job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes (including design, configuration, testing and deployment) to ensure the system functions efficiently and accurately to meet system requirements, ... Works directly with key business stakeholders & external partners to review , analyze and prioritize business requirements and provides process functional and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …repairs as needed Ensure critical spare parts are stocked as needed Review and revise relevant equipment/ systems maintenance documentation Follow all Standard ... The maintenance technician, utilities will maintain facilities, production supporting equipment/ systems and quality, in a GMP regulated manufacturing environment,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members and global colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ensure all ... systems are operating well as designed. Ensures compliance with...controls and accounting policies. Optimizes Financial Disbursement technology through system upgrades and other proven automation practices to build… 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 ... data for the monthly CRB & quarterly QSMR presentations.Fulfills the Quality System audit module site key user responsibilities - represent the Raritan site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Manage the team responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA ... and improvement of QA practices to ensure accurate documentation of all review and release activities for drug products, including manual and electronic… more
- Aequor (San Diego, CA)
- …issues and regularly communicating program information Monitors department service ticketing system to review and triage service requests/inquiries from ... issues and regularly communicating program information Monitors department service ticketing system to review and triage service requests/inquiries from… more
- Eisai, Inc (Nutley, NJ)
- …and commercial requirements that govern the organization's technology systems and information assets.Purpose of role:Oversee IT compliance initiatives ... interruption risks.Change Management: Create a regulatory / non-regulatory change review and change management process.Team Leadership: Lead the global teams… more
- Merck & Co. (Rahway, NJ)
- …of Quality Control and User Acceptance Testing procedures for electronic data capture systems , and the various components that make up the electronic data capture ... system . -They should understand the System Development...CDT SOP's and supporting documentation.May be responsible for compliance review and approval of CDT UAT documentation.Continually monitors for… more
- Aequor (South San Francisco, CA)
- …external Agency partners, addressing inquiries and resolving issues promptly. Ensure timely review and approval of purchase requisitions in Mybuy. Flag and resolve ... on time or by submitting tickets to IT for system issues. Partner with Finance and the Commercial Contracts...experience with contract management and purchase order (PO) requisition systems and processes. Occasional business travel by air or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …presentations in a clear, confident manner. Produce technical documentation of systems and architectures Ensure compliance of solutions to architectural standards ... of risk management standards for current processes, projects, and systems Physical Requirements 10% travel including some international. Qualifications Education… more
- Novo Nordisk Inc. (Omaha, NE)
- …cross-functional team environment required Advanced, in-depth understanding of US healthcare system , payers, reimbursement methods and integrated health systems ... standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications A minimum of 4 years' experience in… more
