- Novo Nordisk Inc. (Plainsboro, NJ)
- …comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and global as applicable ... management Provides SME support to employees working within the quality control process , including consultation on in- process change requests within… more
- Merck & Co. (Rahway, NJ)
- …most technically complex formulation and process development through process tech transfer, scale-up activities, quality investigations, change management, ... Drug Product Development, Estimation and Planning, GMP Compliance, Management Process , Manufacturing Quality Control, Medical Supply Management, Medicinal… more
- Merck & Co. (Rahway, NJ)
- …Python Programming for SDTM Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical writing, able to ... global human health.Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality … more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Technologies, Production Efficiencies, ... a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability to turn strategy ... that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or updated procedural documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within ... Years Experience in quality management in the pharmaceutical industry and quality (GxP) requirements Experience with process mapping, process redesign… more
- Merck & Co. (Durham, NC)
- …the Master Data team with general Material Handling Steward tasksDrive safety, quality and process enhancements throughout the supply chain - Project ... unit of measure (UOM)Lead project to upgrade overall discard process Primary Responsibilities, Continuous Improvement and Stakeholder Collaboration Lead… more
- Merck & Co. (Millsboro, DE)
- …Inventory Management, Life Cycle Logistics, Mammalian Cell Culture, Management Process , Manufacturing Quality Control, Operational Excellence, Packaging ... an interdependent global manufacturing network that's committed to delivering a high quality , reliable supply to customers and patients on time, every time.Our… more
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams ... custom software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom… more
- Merck & Co. (North Wales, PA)
- …data management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to ... Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting… more
- Twist BioScience (South San Francisco, CA)
- …of CAPAs, process deviations, root cause analysisPreparation of product and process quality reports by collecting, analyzing, and summarizing information and ... work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment...trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll Bring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position Developing quality and strategic objectives and strong business understanding of the value chain and customer focus. This role enables and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for PV Deviation process covering NNI ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and ... collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier… more
- Insmed Incorporated (San Diego, CA)
- …software for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as ... lists.OverviewLead Analytical Development Operations function to build out the process development support testing function within analytical development. Will… more
- Eisai, Inc (Exton, PA)
- …the company's discretion.9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, ... collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) ... serves as a strategic leader managing quality and regulatory compliance related to GCPs,...accommodation to participate in the job application or interview process , please contact us by email at ###@insmed.com and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product ... statistical methods, including principal component analysis, etc.Develop and implement statistical process control methodologies and data anlaysis to ensure the … more
- Aequor (Houston, TX)
- …initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major ... and Critical process deviations with the aim at identification of root...the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality...environment. This role will serve as the business process owner for the Corrective and Preventive Actions… more
