- Merck & Co. (Durham, NC)
- Job DescriptionThe Contractor Management Senior Specialist will be responsible for the contractor management system.- Develop a productive working ... with the Global Safety & Environmental (GSE) Standards for contractor management and High-Risk Work. Perform responsibilities and addresses problems with limited… more
- Merck & Co. (Rahway, NJ)
- …individual with a strong background in regulatory affairs and project management to support our cross-functional projects and streamline our regulatory operations ... applications, amendments, supplements/variations, renewals, and annual reports.Ensures the efficient management of regulatory documentation and information to meet internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addition, the Specialist will provide support of the overall Corporate Records Management Program, as assigned.- Corporate Governance: Accountable for all ... of Legal & Corporate Affairs (LCA) including but not limited to: Vendor/Budget Management , Records Management , Litigation, Corporate Governance and other… more
- Merck & Co. (Rahway, NJ)
- …of Quality and Business processes with EQA related to Quality Risk Management .- The incumbent will also drive and/or participate in cross functional initiatives ... and timely corrective actions are implemented (where warranted). Provides project management support of EQA. Assists in the preparation and coordination of… more
- Aequor (Devers, TX)
- Job Description: Field QA Specialist Devens, MA This role is 100% Onsite Work Schedule: Mon - Fri, 2:00 PM - 10:30 PM EST JOB SUMMARY is seeking a Contractor Field ... QA Specialist for the QA Operations organization at the Single...include ensuring manufacturing compliance with applicable procedures and batch records , providing real time review of manufacturing batch record… more
- Merck & Co. (Rahway, NJ)
- …functions of this position are:To assist in writing study specific data management plansTo assist in developing and maintaining databases to collect and retain ... for pharmaceutical and biologic veterinary compounds by following good Data Management practicesTo collaborate with Clinical Research Assistant (CRA) on Case Report… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ.Role ... OverviewThe Operations Support Specialist will be part of the Technical Operations team...floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and… more
- Merck & Co. (Rahway, NJ)
- …scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS). A key aspect of your role will be to collaborate with ... development or programming. Demonstrated technical proficiency in Clinical Data Management Systems (ie, Inform, Inform Architect, Central Designer, Medidata Rave).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety reporting requirements regarding the collection and maintenance of safety records . Relationships Reports to Patient Safety Management . Daily internal ... and opportunities for process improvements; make improvement recommendations to management and support implementation of solutions Assist with department related… more
- Aequor (Fort Worth, TX)
- …management systems according to established procedures and work instructions to begin the records management process. Confirm data in the Records ... monitoring environmental controls and following established procedures to control access.Audit records for internal Records Management compliance. Excellent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. ... be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation… more
- Merck & Co. (Rahway, NJ)
- …and review GxP documentation including but not limited to batch records , specification, equipment qualifications, change records and deviations.Build ... reviewing and approving GxP documentation, quality investigations and change management .Extensive knowledge and experience of drug product processing.Managing and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as intermediate skills ... of projects, tracking progress, identifying risks, and ensuring timely completion.Contract Management support includes but not limited to: Draft, evaluate, negotiate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, New ... Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations...of process materials, subject matter expert for operations inventory management and point of contact for oversight of operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role ... OverviewThe QA Shop Floor Specialist is an exempt level position responsible for the...on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Assurance Document Control Specialist role is an exempt position responsible for supporting...is an exempt position responsible for supporting the document management process within a cell therapy manufacturing facility to… more
- BioAgilytix (Durham, NC)
- …associated SOPs as requiredParticipates in audits/inspections; may lead tours of sample management areaGenerates and maintains records in a regulatory compliant ... life-saving therapeutics to the patients who need them.The Supervisor, Sample Management is responsible for supervising a team of Technicians and Specialists… more
- Merck & Co. (North Wales, PA)
- …achieve business growth.Lead a team of three Associate Directors and one Senior Specialist to ensure optimal patient access for our approved tumors.- Co-Lead the ... Skills Minimum of (10) years combined experience in Pharmaceutical Marketing, Customer Management , Managed Care or Payer MarketingMinimum of (5) years of experience… more
- Koniag Government Services (Washington, DC)
- …IT Systems, LLC,** a Koniag Government Services company **,** is seeking a Senior Records Management Specialist to support **KITS** and our government ... paid holidays, three weeks paid time off, and more. KITS is seeking a Records Management Specialist to work with our client in Washington, DC. KITS ideal… more
- Fluor (Sacramento, CA)
- …Environmental Services Managers and the Authority Director of Environmental Services, the records management specialist works in the Program Delivery ... reports directly to the Deputy Assistant Environmental Services Manager. The records management specialist will work closely with the environmental… more
