- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... for coordinating the authoring, review and approval of new or updated procedural documentation . In addition, this role will work closely with process owners, subject… 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 ... transports required processing equipment, materials, supplies, and products.Executes all documentation and clerical functions necessary to maintain good manufacturing… more
- Merck & Co. (Millsboro, DE)
- …record keeping including charts, log books, and all pertinent documentation . Identifies and addresses compliance, environmental, safety, and process deviations ... operate manufacturing equipment with training-Strong attention to detail and documentation skills are requiredGeneral knowledge of reading, mathematics and computer… more
- Merck & Co. (Millsboro, DE)
- …record keeping including charts, log books, and all pertinent documentation . Identifies and addresses compliance, environmental, safety, and process deviations ... operate manufacturing equipment with training Strong attention to detail and documentation skills are required General knowledge of reading, mathematics and computer… more
- Eisai, Inc (Nutley, NJ)
- …eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined timelinesPerforms eTMF internal reviews, ... detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the COLProvides general enrollment figures to… 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 ... transports required processing equipment, materials, supplies, and products.Executes all documentation and clerical functions necessary to maintain good manufacturing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to support manufacturing operations. Focus areas may include Training, Documentation , Deviations, Change Control and Projects. Drives the coordination and ... process/equipment improvements and data trending/analysis Review/approval of completed process documentation Ability to train others on the manufacturing process and… more
- Genmab (NJ)
- …smooth trial operations. The Sr CTA assists with study documentation , regulatory compliance, communication between stakeholders, and overall trial coordination. ... status updatesPlans and Resource Management:Organize and track clinical trial documentation and reportsAssist in preparation of reports, presentations, and… more
- Aequor (Thousand Oaks, CA)
- …Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to detail and excellent communication skills Values continuous ... in the pharmaceutical industry Must have experience with GMP processes and documentation . Without that fundamental skillset the training for document review tasks,… more
- Aequor (Aliquippa, PA)
- …requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety Collaborate with the LSP to ensure ... to staff and partner groups Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA meetings Liaison between NNI and NNAS departments for preparation of documentation necessary for submission of applications Maintain meeting documentation ... divisions Work with project associate on compilation of information and supportive documentation for FDA briefing packages Work with project leader and team to… more
- Eisai, Inc (Exton, PA)
- …pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to ... validation protocols and reports, and SOPs, along with providing supporting documentation . They formulate the overall strategy for Upstream and Downstream Operations… more
- AUROBINDO (Durham, NC)
- …with supervisory direction.Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.Prepare and/or ... limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation ) when performing the assigned activity.Review of Analytical documents as… more
- Merck & Co. (Boston, MA)
- …approaches for accelerating drug discoveryCreate and maintain the required documentation including Software Development Lifecycle (SDLC) deliverables (GxP and ... and user communication notes with the focus on driving consistency of documentation across the product teamsBe accountable for managing and evolving roadmap for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …equipment in accordance with written procedures. Ensures all calibrations and documentation are in accordance with cGMP, NNUSBPI, and corporate guidelines. This ... measurement disciplines, in accordance with Standard Operating Procedures Maintain documentation and (Regulatory Asset Manager/RAM) database pertaining to calibration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development experience required) in and out of Veeva CRM system.- Documentation : Document various system related documentations such as system configurations, data ... flow processes, test scripts, functional specification, training documentation , etc. Ensure document integrity and version control by leveraging SharePoint and/or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support the day to day execution of validation activities, and related documentation /technical writing overseen by support of more senior Validation Engineers. This ... as needed Write and review protocols, summary reports and other documentation associated with validations Coordinate Validation activities within Novo Nordisk US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …approvals.- Accountable for maintenance and adherence to laboratory data management documentation and guidance such as DS LNR Worksheet template, Textbook Range ... other relevant guidelines.- Accountable for inspection readiness of laboratory data documentation filed/archived in Trial Master File (TMF) according to applicable… more
- Merck & Co. (Rahway, NJ)
- …setting of objectives, budget, resources, timelines, and the study protocol/related documentation .Provide overall leadership and support to the study team. Identify ... leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and reports. Serves as a contact and liaison with other… more
- Merck & Co. (Rahway, NJ)
- …independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience with ... model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support of the following: process characterization (PC),… more
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