- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control /QA Associate I will report directly to the QA/QC...electronic).Maintains related database systems, if applicable, logs and complete forms/ records as required.Adheres to written policies and procedures related… 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...-We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco… more
- Aequor (Thousand Oaks, CA)
- …includes, but is not limited to, the maintenance of training records , laboratory documentation, written procedures, building monitoring systems and laboratory ... logbooks. Preferred Qualifications ? Ability to adhere to regulatory requirements, written procedures and safety guidelines? Ability to evaluate documentation/data according to company and regulatory guidelines? Ability to organize work, handle multiple… more
- Merck & Co. (Rahway, NJ)
- …and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site operations through data ... the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP experience related to plant maintenance… more
- Merck & Co. (Rahway, NJ)
- …will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing ... all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or… more
- Merck & Co. (Durham, NC)
- …osmosis skids, compressed gas systems)Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC))-Clean-In-Place (CIP) ... and safe maintenance and repair of equipment using Hazardous Energy Control ProceduresRequired to wear personal protective equipment including safety glasses,… more
- Merck & Co. (Rahway, NJ)
- …and regulatory filings. Perform independent quality review and approval of batch records , testing data, and related documents required to release or reject product. ... complex document types, as required, including deviations, investigations, change records , analytical method validations, method transfers, analytical methods, specifications,… more
- Merck & Co. (Rahway, NJ)
- …substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in ... design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA).Why Join Us?At-Our Company, you will be… more
- Merck & Co. (Durham, NC)
- …member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual ... will be-responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety,… more
- Twist BioScience (South San Francisco, CA)
- …Lead the design, development, and continuous improvement of electronic batch records within the MES, ensuring accurate capture of manufacturing data, deviation ... adoption, effective GxP training programs, and adherence to change control procedures for custom software releases.QualificationsBachelor's degree in Computer… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of ... timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective and preventive actions.6. Oversee and coordinate the… 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 ... willingness to upskill.Experience with GitHub or similar platforms for version control and collaboration.Understanding of data modeling, ETL processes, and data… more
- Merck & Co. (Rahway, NJ)
- …be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination ... management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO 11608… more
- Merck & Co. (Millsboro, DE)
- …processes and procedures against corporate and regulatory policies.Review production records for completeness and compliance to departmental and/or Site Standard ... Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance… more
- Novo Nordisk Inc. (Orlando, FL)
- …trends, and competitors' products or services Maintain required activity records /reports, including timely and accurate transmission of call data Participate ... and tasks to achieve maximum customer effect and sales volume Prudently control company property consistent with applicable company policies and procedures and legal… more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …trends, and competitors' products or services Maintains required activity records /reports, including timely and accurate transmission of call data Understand ... and where they currently position NNI products and devices Exercises prudent control over samples and other company property in accordance with company policies… more
- Merck & Co. (Rahway, NJ)
- …and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence ... verification, automation/process development, design validation, human factors evaluations and control strategy.Deep and broad working knowledge of pharmaceutical vaccine/biologic/small… more
- Novo Nordisk Inc. (Dayton, OH)
- …trends, and competitors' products or services Maintain required activity records /reports, including timely and accurate transmission of call data Participate ... that maximize the opportunity to call on targeted customers Exercise prudent control over samples and other company property in accordance with company policies… more
- Merck & Co. (Durham, NC)
- …leak detectors) to facilitate analysis and repair of equipment and control systems.Identifies revisions, deletions, or additions to the calibration and maintenance ... Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
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