- Aequor (Swiftwater, MN)
- …Update cGMP forms (1-2) per week as required for any updated MSAT procedures b. MSAT document Periodic Review c. Review Record and System (R&S) periodic ... Job Summary: The MSAT Support Tech will support Data Pack, Document Coordination, Sample Coordination and Training Coordination for the Swiftwater Manufacturing… more
- Merck & Co. (Durham, NC)
- …with media, biological drug substance and drug product.Strong Background in cGMP document review and approval.Strong background in cGMP compliance standards ... and our Company's Quality Management System focusing on batch record review , process/aseptic observations, critical site review , critical alarm management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational input into study protocol profiles, final protocols and amendmentsLead document review & coordination for the protocol and amendments. ... bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through… more
- Aequor (Framingham, MA)
- …support to the operations department, including OTF support for critical operations Conduct review of testing results. Review document and complete ... operations to ensure a culture of continuous compliance. Perform batch record review . Perform quality inspections of intermediates and finished goods. Perform … more
- HEPCO, Inc. (New Brunswick, NJ)
- …Ensure that program documents are up-to-date in coordination with the client. Manage document review /approval processes with the client. Review and analyze ... program pipeline data and reporting. Track, investigate, and resolve customer and Trade Ally escalations. Gain an in-depth understanding of project processing, savings methodologies, and best practices. Collaborate with cross-functional teams to implement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA, Document Control Specialist (1st Shift) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Document Control Specialist (1st shift) role is an exempt...with workflow handling and electronic system usageManage the periodic review process for proceduresIssuance of batch related documentation in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review and document CRO-generated reports, such as site monitoring ... Study Oversight Plan (CSOP).Responsibilities Prior TMF experience required!- Reconcile the TMF document trackers generated by the CRO with the document archive.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Batch Record & Document Coordinator as part of the Technical Operations team based in Raritan, NJ. ... forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance with written… more
- Aequor (Oceanside, CA)
- Job Title : Document Specialist Location : Oceanside, CA 92056 Duration : Until 09/05/2025 Job Summary: Responsible for owning and overseeing all Site Operations ... helps to define and adhere to documentation guidelines by managing document change requests, working closely with technical collaborators, redlining documents, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of subordinates with direct/indirect referral: none Essential Functions Document management: formatting, scanning, printing, distribution, organizing, approval ... uploading documents and attachments, maintain metadata, and route documents for review and approval Support engineering with coordination, processing, tracking and… more
- Merck & Co. (Rahway, NJ)
- …product. Make independent batch release or reject decisions.-- Conduct independent auditing, review , and approval of diverse and complex document types, as ... Global Development Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP)… more
- Aequor (Thousand Oaks, CA)
- …for our partners! Required Competencies and Skills: Key Responsibilities:1. Lead the review , drafting, and negotiation of contracts for members of the healthcare ... identifying potential process improvements and manage multiple assignments at one time. Review and either approve payments or triage errors to the appropriate staff… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters, and various other related projects (litigation readiness, e-discovery, document collections, etc.)). This position is also responsible for providing ... and assisting in litigation matters, investigating and responding to fact and document discovery, collecting documents, and responding to subpoenas and other legal … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other ... Ensure key messages are clear and consistent within and across documentsCritically review documents produced by other writers for scientific content and alignment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PGC process by conducting intake and organizing all PGC requests in Electronic Document Management System (EDMS). Conduct independent initial review of all ... determine if they comply with policy and procedure requirements and warrant PGC review ; make decisions regarding actions to be taken on each request, communicate… more
- Fidelity Investments (Jersey City, NJ)
- …innovative solutions to increase productivity.Define Performance Test Strategy Document : set approach, metrics, benchmarks, baseline, user response requirements ... reports about the product/product component's readiness for release to users. Review and recommend improvements to existing test procedures.Suggest new tools… more
- Fidelity Investments (Boston, MA)
- …to facilitate meetings with various audiences, drive to decisions, and document outcomes. Excellent interpersonal and communication skills with which you build ... to go through a background investigation, detailed in this document , and may be asked to provide additional documentation...not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role… more
- Merck & Co. (Durham, NC)
- …This position will support the technical roles of Quality in collaboration, review , and approval of cGMP documentation in the following areas:- qualification ... documentation for sustained compliance with QMS guidelines. Support technical quality review of critical utilities and facility environmental control systems through… more
- BioAgilytix (Durham, NC)
- …maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networksAssist in document ... through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any gaps or deviations in… more
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