- Aequor (Athens, GA)
- …document management systems . Must be able to follow precise computer system instructions with high attention to detail and minimal oversight. Must balance ... Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems . Electronic Document… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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...approval of standard operating procedures and any other required documentation .Collaborate with functional departments to resolve issues.Perform tasks in… more
- Merck & Co. (Rahway, NJ)
- …, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: Monitor ... (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements and processes pertaining to system management for… 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
- Merck & Co. (Rahway, NJ)
- …activities.- Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP ... GMP and developmental use.- Author, review and approve GMP procedures and documentation , with an emphasis on Qualification and Validation plans around equipment,… more
- Merck & Co. (Rahway, NJ)
- …packages to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such ... as master inventory lists, qualification documentation , calibration documentation , computer system inventories Support internal and external quality audits… more
- Repligen (Hopkinton, IA)
- …is responsible to actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the document control department in ... processing documentation requests. They will work closely with cross-functional teams...to meet established deadlines (paper and electronic).Maintains related database systems , if applicable, logs and complete forms/records as required.Adheres… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… 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 ... qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment,… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… more
- Aequor (Thousand Oaks, CA)
- …Manager, this role will be pivotal in identifying, documenting, and adapting documentation and process flows to support system and procedural transitions ... stakeholders to support the identification, revision, and creation of procedures and documentation that align with system changes. Manage and maintain… 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
- 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 ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe...define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS), and ensure compliant data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …API requirements (no development experience required) in and out of Veeva CRM system .- Documentation : Document various system related documentations such as ... and remediating User issues. Provide support across all areas of CRM system development lifecycle (SDLC) including creating training documentation for all… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… more
- AUROBINDO (Durham, NC)
- …staff members and management on policies, as well as providing documentation .Assist with policy administration including managing leave of absence requests, FMLA, ... and producing reports, as needed. (currently utilizing Paylocity as our HRIS system )Assist in talent acquisition and recruitment processes by creating and posting… more
- Eisai, Inc (Raleigh, NC)
- …with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation , and reporting of quality goals ... with procedures to support timely product lot disposition.Maintain associated documentation and records electronically in accordance with internal standards.Support… more
- Merck & Co. (Durham, NC)
- …lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support. ... investigations as needed and follows site procedures in the documentation of Quality Notifications and Corrective/Preventative ActionsExecute test method… more
- Insmed Incorporated (San Diego, CA)
- …role provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national ... Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor… 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
