- Aequor (Thousand Oaks, CA)
- …of Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and ... to add value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of interactions and collaboration… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position...cleaning to ensure it is safe ready for use Change out pipet soakers on a weekly basis Receive incoming ... chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management Provides SME support to employees working within the quality control process, including consultation on in-process change requests within the ... This role fulfills the PV Oversight function in PV quality control processes, as well as providing...it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity… more
- Merck & Co. (Rahway, NJ)
- …GMP Auditing, Interpersonal Relationships, Management Process, Manufacturing Processes, Manufacturing Quality Control , Process Improvements, Quality ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Tris Pharma (Monmouth Junction, NJ)
- …liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... and reports, as well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required… more
- Merck & Co. (Rahway, NJ)
- …influence across the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to ... standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will have strong… more
- Merck & Co. (Rahway, NJ)
- …to ensure scalable and efficient data models and pipelines.Use GitHub for version control of scripts, data models, and BI artifacts to ensure collaboration and code ... quality .Experience leveraging Databricks for big data processing, advanced analytics,...to upskill.Experience with GitHub or similar platforms for version control and collaboration.Understanding of data modeling, ETL processes, and… more
- Twist BioScience (South San Francisco, CA)
- …ensuring user adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree ... with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About… more
- Novo Nordisk Inc. (Durham, NC)
- …processes, machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...self development & initiative to understand the site process control systems, data management systems, and differing data sources… more
- Novo Nordisk Inc. (Orlando, FL)
- …audience needs, share learning objectives and local challenges, provide feedback on quality of presentation) to provide quality balanced and relevant ... programs and services, establish alignment among Endocrinologists around the need for change , the value propositions the new product, program or service represents… more
- BioAgilytix (Durham, NC)
- …operational data to lay the groundwork for future predictive models focused on quality control , lab maintenance, and operational forecasting.Assess core lab and ... a foundational data governance framework, with hands-on responsibility for data quality , access control , and compliance protocols.Define standards, build … more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program ... deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective and preventive actions.6. Oversee… more
- Merck & Co. (Durham, NC)
- …coordination leadership and implementation of troubleshooting activities and change control .On-floor support of manufacturing activities.Identify and ... member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual… more
- Novo Nordisk Inc. (Dayton, OH)
- …disease achieve greater health outcomes. If you are passionate about being a force for change , not afraid to take risks and challenge the status quo, and are looking ... that maximize the opportunity to call on targeted customers Exercise prudent control over samples and other company property in accordance with company policies… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued ... for problems associated with investigations Completes accurate and timely assessments associated with change control activities Ensures change control … more
- Merck & Co. (Durham, NC)
- …solving and troubleshooting Preferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to ... Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times,… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, 12 ... participate and ensure an effective "hand shake" during the Operations Shift Change Tiers and Maintenance Tier 1.Properly distribute the shift maintenance work load… more
- Insmed Incorporated (San Diego, CA)
- …strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing ... judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget.Update group members on background and… more
- BioAgilytix (San Diego, CA)
- …the development and revision of Computer System Validation procedures and policies (validations, change control , data integrity), following 21 CFR Part 11, Annex ... procedures (SOPs) including those for account management, systems configuration, change control , and incident handlingAdditional ResponsibilitiesAt all times,… more
- Merck & Co. (South San Francisco, CA)
- …developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate ... focused on bringing AI/ML approaches to bear to improve the speed and quality of decision-making in drug discovery and development. PDMB aims to leverage Generative… more
