- 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...preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.GxP Quality System… more
- Aequor (Thousand Oaks, CA)
- …Engineering areas/staff in the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on the floor, electronic ... documentation and operations according to company procedures. Experience working with Quality Systems , Strong organizational skills and ability to manage… more
- Aequor (Thousand Oaks, CA)
- …but is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory logbooks. ... required, as full training will be provided. Strong attention to detail, good documentation practices (GDocP), and comfort with lab notebooks and SI pages are… more
- Merck & Co. (Rahway, NJ)
- …activities.- Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP ... investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/ system changes, execute periodic reviews and support Quality … more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… 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 ... chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide expertise ... actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for...Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as… more
- Merck & Co. (Rahway, NJ)
- …inventory lists, qualification documentation , calibration documentation , computer system inventories Support internal and external quality audits and ... packages to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics ... and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for...Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as… more
- Repligen (Hopkinton, IA)
- …manner while also serving as a resource for the review of quality documentation received from interdepartmental sources.ResponsibilitiesWorks with subject matter ... Director.This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the… more
- Twist BioScience (South San Francisco, CA)
- …perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system ... cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Eisai, Inc (Raleigh, NC)
- …Batch Records (MBRs)Assist with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation , and ... .Familiarity with applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition ... staff members and management on policies, as well as providing documentation .Assist with policy administration including managing leave of absence requests, FMLA,… more
- Merck & Co. (Durham, NC)
- …providing on demand support to other functional groups, completing basic automation system changes, and assisting with documentation updates.Learns and supports ... of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will… more
- Merck & Co. (Durham, NC)
- … Quality (SHEQ), Safety Procedures, Shift Work, Standards Compliance, Systems Troubleshooting {+ 3 more}-Preferred Skills:Job Posting End Date:08/1/2025 *A job ... 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
