- Legend Biotech USA, Inc. (Raritan, NJ)
- …system users with workflow handling and electronic system usageManage the periodic review process for proceduresIssuance of batch related documentation in ... and document issuance and reconciliation.Key Responsibilities Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within company policies, procedures, and all applicable regulations.Key Responsibilities Review documentation for all manufacturing activities executed in ... accordance with Good Documentation Practices (GDP). Review documentation for miscellaneous activities executed in accordance with Good Documentation … 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …CAPA & Deviation management to ensure timely closure of any observationsAuthor, review , and approve GMP procedures and documentation , with an emphasis ... on operation's SOPs and Work InstructionsFacilitate the management of changes to the development & production areas; execute periodic reviews, and support Quality Management System (QMS) activitiesQualificationsBachelor's Degree in Engineering or Science plus… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …logically and acts decisively.Key Responsibilities Prepares and reviews documentation independentlyResponsible for QC sample and retain managementKnowledge and ... system (LIMS)Prepare documents and coordinate Sample shipment (internal and external shipments) Review logbooks and/ or LIMs to align physical quantities of samples… 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
- SMBC (New York, NY)
- …and experienced program manager to join our team. The Program Management and Documentation VP will be responsible for overseeing and managing various programs and ... requirements, internal policy, and industry standards. Develop clear and concise documentation , including user manuals, process guides, and training materials, to… more
- embecta (Parsippany, NJ)
- …role within embecta, ensuring the efficient management and compliance of documentation processes that support the development, manufacturing, and distribution of ... Quality Specialist ensures the accuracy, accessibility, and security of documentation critical to regulatory success, operational excellence, and product quality.… more
