- Insmed Incorporated (Bridgewater, NJ)
- …as well as reviewing and tracking CAPAs.Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices ... Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA… more
- Tris Pharma (Monmouth Junction, NJ)
- …status updates, mitigation strategy/plans, escalation of issues for trial or program level deliverables to senior management, etc.); Develops, implements, ... an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical Operations provides expert… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Manager of Operations - Continuous Improvement and Projects as part of the ... an effective, holistic continuous improvement, problem solving and project management program to improve safety, compliance, cost, process stability building … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Associate OpEx Engineer as part of the Technical Operations team based in ... and executes against an effective, holistic continuous improvement and problem-solving program to improve safety, compliance, cost, process stability building … more
- Catalent (St. Petersburg, FL)
- …support to the Catalent St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch ... regarding status of daily work.Serve as administrator (or back-up) to quality systems as assigned (Documentum, TrackWise, ComplianceWire) including coordination… more
- Aequor (Thousand Oaks, CA)
- …and Engineering staff in the execution of their processes, procedures, and use of quality systems . Duties include but are not limited to: Purposeful presence on ... on the manufacturing floor. Detail Oriented, Team player and Quality Experience. The Sr . Associate Quality.... Associate Quality Assurance position supports 's Quality Assurance program under the Plant QA… more
- Catalent (San Diego, CA)
- …5 years' experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations, investigations, CAPAs ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma...forms.Must have a demonstrable record of implementing and maintaining quality systems ; laying out a strategic plan… more
- Merck & Co. (Durham, NC)
- …maintenance (PM) plans/calibration procedures, task lists, etc., as required.Work compliance systems for maintaining PM program and assessing equipment - ... Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and… more
- Merck & Co. (Durham, NC)
- …equipment performance, and assist in writing maintenance/calibration work instructions. The Senior Calibration Technician will use computerized systems such as ... within the site is seeking a highly motivated individual for a Senior Calibration Technician position. This individual will partner with Maintenance management, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...Major tasks will include implementing and maintaining existing laboratory systems and instruments, enabling solutions for capturing data from… more
- Catalent (Harman, WV)
- Position Summary The Director, Quality Systems is responsible for the management and oversight of the core quality systems , including ... , audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality … more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... Support validation activities associated with changes to existing & new systems . Process equipment includes synthesizer, deprotection systems , UF/DF,… more
- Merck & Co. (Boise, ID)
- Job DescriptionDescription:The technician fabricates and wires equipment used in the RFID systems for Fish and Wildlife. Assists in the RMA process for repairs of ... and technical manuals using knowledge of electronic, and mechanical systems or components.Develop and oversee assembly procedures.Troubleshoot circuit level… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical ... clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Designs and develops complex programming algorithms.Ability… more
- Aequor (Thousand Oaks, CA)
- …or more high-level, complex non-technical projects within the constraints of scope, quality , time, and cost, to deliver specified requirements. Projects may be ... MS Word, Visio, MS PowerPoint, MS Excel, and Smartsheet skills; understanding of systems for sharing and collaboration ; excellent communication skills to work with… more
- Merck & Co. (South San Francisco, CA)
- …development of our Company's biologics pipeline by evaluating critical quality attributes, selecting manufacturable drug candidates, and ensuring efficient ... development team.Serve as a CMC subject matter expert in Discovery program core teams.Interface with Discovery, Analytics, and Pharmaceutical Science teams in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along ... diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business strategy within...point person for all GxP matters for the Global Program Head and the Global Program Team.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of quality systems to ensure product reliability, quality , efficacy, and complianceOversee compliance auditing program to fulfill regulatory ... subject matter expert on GxP compliance. He/she will also serve as key customer-facing senior quality leader to ensure the full alignment between customers and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Quality . Hires and develops employees within the department. Coordinates quality systems related activities among impacted individuals, departments, sites ... for batch record review activities for the site. Oversees quality shop floor program to ensure compliance...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties… more
