- Merck & Co. (Durham, NC)
- …SAP, Veeva and/or GLIMS. Experience in deviation management with focus on quality review and approval. Experience in Aseptic processing, aseptic observations, ... Job DescriptionPosition Description: Specialist, Quality Assurance 2nd Shift - Our Company constructed...Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and… more
- Merck & Co. (Durham, NC)
- …Product Quality Complaint investigations, Adverse Event investigation, and Quality systems metric generation.-By providing administrative support, the ... existing Deviation/ Corrective Action and Preventive Action Management and Complaint/Adverse Event Quality Systems , which will be done in concert with strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and control access to any systems used to support audits/inspections.Provide support to quality systems team, ad hoc, for activities such as annual product ... review , site risk register, or internal quality ...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.RequirementsA minimum of… more
- Aequor (Newbury Park, CA)
- …Will consider those that have significant years of direct experience in lieu of education requirements Org Unit: GxP Computer Systems Quality Assurance 13228 ... Validation program Able to act as SME for multiple Quality processes (eg Deviations, CAPA) Review and... Review and Approve SOPs and associated documents Review /Approve Periodic Reviews for GxP Systems May… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety information, including complete and accurate detail processed into the correct systems Quality monitoring activities to include CRM system case ... members, IT and Patient Safety on automation and technical enhancements that may make quality review more efficient or scalable Analyze call center data to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch related recordsPerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsReview and approve SOPs, and other ... EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA)Operational experience with electronic quality systemsExperience with Document Management Systems (TruVault/Veeva) is… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on and manage multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses ... and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Job duties performed routinely require exposure ... is seeking QC Analyst II as part of the Quality team based in Raritan, NJ. Role OverviewThe QC...final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data. Utilize electronic systems … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …provides direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring ... Operations and perform acceptance quality limit (AQL) inspection Perform Quality Assurance compliance review of manufacturing, maintenance, and quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation of testing.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as ... communicate key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Summary: The maintenance technician, utilities will maintain facilities, production supporting equipment/ systems and quality , in a GMP regulated manufacturing ... repairs as needed Ensure critical spare parts are stocked as needed Review and revise relevant equipment/ systems maintenance documentation Follow all Standard… 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), ... and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other groups such as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …breakdowns.cGMP manufacturingMaintenance and facilities managementComputerized maintenance management systems (CMMS) Quality Management knowledge, including ... accordance with all cGMP, company policies, and appropriate regulatory standards.Performs work review , approval and close out of work orders, including management of… more
- Merck & Co. (Baton Rouge, LA)
- …technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... efficient operation of variety of automated processing and information technology systems .- Leads in installing and placing new equipment into operations.- Develops… more
- Aequor (West Greenwich, RI)
- …and Environmental/Water monitoring. 2. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures. 3. ... Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain specialized laboratory… more
- Aequor (South San Francisco, CA)
- …the Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high- quality clinical trial data insights and to offer ... and conduct predictive analysis to increase the efficiency of clinical data review and clinical operations with the ultimate goal of driving data-driven… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in ... oriented and highly organized QC Testing Scheduler to join our team for Quality Control. The ideal candidate will manage and maintain our automated scheduling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and ... and Strategy:Responsible for medical coding deliverables for assigned programs meeting quality and time expectations for both in-house and outsourced studies.… more
- Merck & Co. (North Wales, PA)
- …other Company field-based employees such as the Account Executives, Integration Delivery Systems leaders as well as other members of our Company's extended team.This ... as physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and office managers.-- Within their geography there are a… more
- Insmed Incorporated (San Diego, CA)
- …EDC systems (ie, RAVE) and data analysis tools (ie, J- Review ) requiredStrong medical writing and presentation skillsBasic understanding of biostatistics and data ... to clinical development and operations, regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring the… more
