- Merck & Co. (Rahway, NJ)
- …such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory… more
- Merck & Co. (Durham, NC)
- …HVAC Systems, Hydraulic Systems, Instrumentation Systems, Instrument Calibrations, Maintenance Management , Maintenance Planning Software, Management Control ... and specification data within the computerized calibration and maintenance management system.Troubleshoots equipment and performs necessary repairs. Utilizes various… more
- Merck & Co. (Rahway, NJ)
- …and influence across the enterprisePreferred Experience and Skills: Project management , including change control and equipment qualificationSAP experience ... Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management , Regulatory Compliance, Regulatory… more
- Aequor (Thousand Oaks, CA)
- …Agar plates. Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy. Job ... position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to directly...against SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position… more
- Merck & Co. (Durham, NC)
- …Communication, Customer-Focused, Data Analysis, Financial Forecasting, Inventory Accuracy, Inventory Control Management , Logistics Management , Logistics ... the Supply Chain Logistics Strategy Leader will be responsible for the development, management , and growth of our warehousing and logistics operations, both on the… more
- Merck & Co. (Durham, NC)
- …in problem solving and troubleshooting Preferred Experience and Skills: Project management , including change control and equipment qualificationSAP experience ... Required Experience and Skills: Strong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with GMP manufacturing… 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 ... control strategies, statistical analysis, and advanced statistical methods for...regression, multivariate analysis, and design of experiments.Demonstrated leadership and management experience, including the ability to build and develop… more
- Aequor (West Greenwich, RI)
- …for activities including microbiology & analytical testing, sample and data management and equipment and instrumentation operation and maintenance in a highly ... dynamic, team environment. This position will be responsible for one or more of the following activities: 1. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring. 2. Perform testing and possible data review… more
- Repligen (Hopkinton, IA)
- …Biological Science or other science related disciplineMinimum 1-2 years' experience in Document Control in an ISO 9001 certified Quality Management System or ... OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality...to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the… more
- Aequor (Swiftwater, MN)
- …position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming ... training curricula. Perform all scheduled activities defined by laboratory management to meet demands of Production, Method Development, Validation, Independent… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... in accordance to written methodology Analyze data against approved specifications, notifying management of any OOS and aberrant results Actively participate in root… more
- Merck & Co. (Millsboro, DE)
- …Inventory Management , Life Cycle Logistics, Mammalian Cell Culture, Management Process, Manufacturing Quality Control , Operational Excellence, Packaging ... Aseptic Manufacturing, Cell Cultures, cGMP Compliance, Communication, Customer Relationship Management (CRM), Data Analysis, Employee Performance Standards, Internal Customers,… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... experts within the broader DD&T team (eg design verification, device risk management , human factors, technical integration, assembly automation, etc.), as well as… more
- BioAgilytix (San Diego, CA)
- …systemsFollows standard operating procedures (SOPs) including those for account management , systems configuration, change control , and incident ... and revision of Computer System Validation procedures and policies (validations, change control , data integrity), following 21 CFR Part 11, Annex 11, GxP, and… more
- Merck & Co. (Durham, NC)
- …approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control ).- Supply Chain Management ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Novo Nordisk Inc. (Durham, NC)
- …processes, machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using ... Own self development & initiative to understand the site process control systems, data management systems, and differing data sources (PCS, MES, SAP, PI… more
- Twist BioScience (South San Francisco, CA)
- …driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills and ability to ... Bioscience is at an exciting phase of growth in business. The Program Management Office (PMO) is seeking an experienced, highly-motivated program manager to enable… more
- Merck & Co. (Rahway, NJ)
- …Management , Employee Training Programs, GMP Auditing, Interpersonal Relationships, Management Process, Manufacturing Processes, Manufacturing Quality Control , ... for all assigned projects and communication of status to the Management Team. Build collaborative working relationships and effective communications with all… more
- Twist BioScience (South San Francisco, CA)
- …Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience with ... Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... to lay the groundwork for future predictive models focused on quality control , lab maintenance, and operational forecasting.Assess core lab and operational data for… more
