- 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
- Merck & Co. (Rahway, NJ)
- …during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities such as site ... manufacture and/or regulatory inspections. Independently performs audits of batch documentation , data, information, procedures, equipment and systems , and/or… more
- Aequor (Thousand Oaks, CA)
- …plates. Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy. Job Summary ... This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to...SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will… more
- Insmed Incorporated (San Diego, CA)
- …(Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections ... Practice.Provide support and coaching to other staff members to develop additional quality and auditing resources.Manage quality documentation in Veeva.… 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)
- …skills Excellent communication skills Time management Proficient computer skills (ie documentation systems , databases and spreadsheets). Bachelor's degree OR ... for sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and… 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
- 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
- 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 (West Greenwich, RI)
- …routine laboratory procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate ... and maintain specialized laboratory equipment and instrumentation. 5. Participate in laboratory investigations and audits as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times,… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered… 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
- 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
- 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
- Merck & Co. (Durham, NC)
- …production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered ... team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a night shift position, 12 hour… 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
- 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
- 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
- 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
- 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
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