- Legend Biotech USA, Inc. (Raritan, NJ)
- …labels, forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance ... Operations team based in Raritan, NJ. Role OverviewThe Batch Record and Documentation Coordinator will work in a detail-oriented compliant manner coordinating the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation , in accordance with Good Documentation ... to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support Floor Spot-check,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on the type of changes made and managing printing of documentation and labels required for Technical Protocol runs.Key Responsibilities Will be accountable ... incorporate all latest regulatory and quality requirements.Track relevant KPIsEnsure periodic review of all GMP documents are completed on time.Support … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.Assists in ... master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.Create, review and approve relevant QC documents, ... SOP's and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …activities.Execute, own, assess and participate in the creation, revision and review of change controls, SOPs, and other documentation .RequirementsBachelor's ... technical writing skills to author manufacturing SOP's or technical documentation as needed.Experience with process modelling and optimization.Experience with new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). ... appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with business process owners to monitor the effectiveness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to the policy ... monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the...systemAdvise speaker bureau vendor to provide all back up documentation ( ie F&B receipt, AV, sign in sheet,… more
- Genscript USA Inc. (Piscataway, NJ)
- …lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals ... commissioning of MEP systems, ensuring performance verification and turnover documentation are complete. Support construction scheduling, cost control, and quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety, with cross-functional working relationships within Case Processing, Medical Review , Submissions and Compliance and the centralized teams (eg, Training ... and Documentation , Quality, Supplier and Contract Management and Digital Enablement)....compliant safety case processing Support inspection readiness by preparing documentation and participating in internal and external inspections Serve… more
- Merck & Co. (Rahway, NJ)
- …for and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... in equipment design and testing as well as preparation, review , and completion of GMP documentation . Support...as preparation, review , and completion of GMP documentation . Support compliance with Industrial Hygiene (IH) program by… more
- Merck & Co. (Rahway, NJ)
- …improvements or training may be requiredParticipate in System Development Lifecycle (SDLC) documentation review and maintenance of the business standards for ... Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality Assessments, Documentation Review , Employee Training Programs, FDA Regulations, IT… more
- Sampled (Piscataway, NJ)
- …Own and execute the monthly close process, including preparation and review of journal entries, accruals, and reconciliations. Perform and oversee bank ... the annual financial audits, including preparation of audit schedules and documentation Drive continuous improvement in accounting processes, leveraging systems such… more
- Merck & Co. (Rahway, NJ)
- …milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) ... analytical test method technology transfer process.Skilled in laboratory good documentation practices and electronic documentation systems.Self-motivated with… more
- Merck & Co. (Rahway, NJ)
- …to GMP procedures, strong attention to detail in completing GMP documentation , proficiency in electronic systems, and participation in continuous improvement ... culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need.-Supply -… more
- Merck & Co. (Rahway, NJ)
- …Support compliance audits, inspection activities, and investigation/CAPAs.-- Author and review technical documents. Complete assigned work within established project ... needs of the department. Understanding and adherence to ALCOA principles for documentation . - Strong organizational skills and ability to manage work to meet… more
- Merck & Co. (Rahway, NJ)
- …the team accountable to deliver on priorities.Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing ... reports, technical memos and supplier assessmentsRemain informed of current Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry standardsMinimum… more
- Eisai, Inc (Nutley, NJ)
- …use of funds, and economic trends. Additionally, this individual will review cash requirements, plans and prepare short-term investments/borrowings to optimize daily ... opening, modification and closing process and ensure all bank account documentation (ie Corporate Resolutions, Authorized Corporate Signers & Bank Signers) is… more
- Hovione (Cranbury, NJ)
- …- To execute, with supervision, the production/HSE processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an ... transferred Operators from other areas. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility… more
- Reform (New York, NY)
- …You'll support both clients and internal teams, resolve issues proactively, and review designer orders for accuracy before they move into production. A strong ... friendly, and solution-oriented support to clients throughout their projects Review designer orders before production to ensure accuracy, completeness, and… more
