- 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 ... quality assessment management Provides SME support to employees working within the quality control process , including consultation on in- process change… more
- Merck & Co. (Rahway, NJ)
- …As the facility is nearing the completion of its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to ... technically complex formulation and process development through process tech transfer, scale-up activities, quality investigations,...based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP… 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
- Knowhirematch (Ames, IA)
- …and increase throughput. *Support internal audits and corrective action planning related to process and product quality . * Lead cross-functional teams in ... Job Title: Quality & Manufacturing Process Engineer Location:...and production, ensuring design intent is maintained through launch. * Lead pre-production process validation, including PFMEA, control… 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 ... the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines,...project to align pallet quantity / unit of measure (UOM) Lead project to upgrade overall discard process … 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems processes within… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and ... for applying deep subject-matter expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Company is a trusted global leader in human and veterinary medicine, dedicated to preserving and improving health, well-being, and performance.- ... vaccine manufacturing facility in Durham, North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate… 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
- BioAgilytix (Durham, NC)
- …between systems, with a focus on operational efficiency and data integrity. Data Quality & Compliance Automation: Use Robotic Process Automation (RPA) tools like ... That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can… more
- Repligen (Hopkinton, IA)
- OverviewThe Manufacturing Line Lead 2nd Shift reports to the Production Manager and helps in performing all tasks involved in the production of Repligen's fluid ... will play a key role in ensuring that the department's safety, quality , and production goals are met.ResponsibilitiesSupervise and coordinate the activities of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping KOL engagement strategy. They ... areas (TAs) and segmentation to inform actionable plans. KOL Experience Strategy: Lead the development and execution of KOL experience strategies and ensure… 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
- Insmed Incorporated (San Diego, CA)
- …to operate solutions to enable rapid process development. May act as a Process Development Team representative as an Analytical Lead for a drug program.Key ... (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe...trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs… more
- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic ...accommodation to participate in the job application or interview process , please contact us by email at ###@insmed.com and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Eisai, Inc (Exton, PA)
- … Lead and assist in troubleshooting upstream and downstream process , product, and equipment issues and deviations. Provide timely reporting, investigation, ... the company's discretion.9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control,… more
