- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Services Lead plays a key role in overseeing the development, validation , implementation, and integration of GxP-regulated systems across the organization. This ... position ensures that all global systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best… more
- Cytiva (Muskegon, MI)
- …for the validation strategy and maintain ownership of the Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is ... Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation (CSV) protocols… more
- Aequor (Thousand Oaks, CA)
- …priorities. 7. Excellent knowledge of and experience with processes involved in quality analytical labs, validation , manufacturing, quality assurance, ... possible remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details:… more
- Twist BioScience (South San Francisco, CA)
- …Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and ... analytics, and data visualization capabilities to support operational decision-making and quality reviews.Compliance & Validation : Ensure our custom MES… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for… more
- Repligen (Waltham, MA)
- …and quality .Support the release process by validating build quality and readiness for production.QualificationsBachelor's degree in Computer Science, ... OverviewWe are seeking a detail-oriented Software Quality Test Engineer to join our team. In this role, you will focus on ensuring the reliability, functionality,… more
- AUROBINDO (Durham, NC)
- …mentionedQualifications - Skills & RequirementsProven expertise in reviewing and approving validation deliverables for key quality and laboratory systems such ... consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance, Quality control, and regulatory affairs. In addition to… more
- BioAgilytix (Durham, NC)
- …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 ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- BioAgilytix (Durham, NC)
- …ensures timely response to all system alarmsDevelops, implements, and maintains EMS validation documents in internal Quality Management SystemsServes in the ... and environmental monitoringUnderstanding of the equipment qualification and software validation processes for 21CFR Part 11 systemsVersatility, flexibility, and… more
- Merck & Co. (Durham, NC)
- …in process automation in a GMP environment.Experience programming Emerson DeltaV. Computer system validation and systems life-cycle development methodology ... Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . Our company is expanding its global recombinant human… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.-Position Description -This is a… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …System while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse and ... connected and functional Work with PM to conduct system testing and validation to ensure proper operation Programming and Configuration Assist with contractors to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will need to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements ... that all asset qualification activities are properly supporting for manufacturing, quality control, supply operations and for the site's requirement.Drive the… more
- Merck & Co. (North Wales, PA)
- …in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical ... - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (Durham, NC)
- …12+ required including Batch control Minimum of 4 years of GMP Computer validation and systems life-cycle development methodology experience required. Proven ... embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- -Supports a large spectrum of sophisticated… more
- Merck & Co. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.The Maurice R. Hilleman Center for… more
- Merck & Co. (North Wales, PA)
- …in ensuring that project plans are executed efficiently with timely and high- quality deliverables. Serve as the statistical programming point of contact and ... assigned projects. Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area (TA) standards and following… more
- BioAgilytix (Durham, NC)
- …of life-changing therapies. In this role, you'll focus on method validation and sample analysis for biologics and biomarkers using immunoassay platforms-primarily ... help execute complex studies, troubleshoot technical issues, and generate high- quality data.Essential Responsibilities:Compile/process data (make power export)Prepare summary tablesPeer… more
- Repligen (Waltham, MA)
- …candidate will play a key role in ensuring that the department's production and quality goals are met. The applicant will be the key interface between manufacturing, ... quality and R&D. Hands-on mechanical aptitude and an exceptional...processes as needed Develop standardized documentation including SOP's, training, validation of equipment, and reports Provide accurate and timely… more
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