- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe CAR-T Compliance Auditor (Sr. Investigator) will be a key member...supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal audits.Collaborate with site personnel to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, ... quality indicating data and identifying trends.Contribute to maintain investigation compliance metrics.Support investigation process improvement initiatives.Job duties performed may… more
- Genmab (NJ)
- …organize, prioritize, and work effectively in a constantly changing environmentStrong compliance knowledge and adherence to corporate compliance policiesCurrent ... of FDA, OIG, ICH, GCP, PhRMA Code, HIPAA and other compliance regulations and guidelines relevant to industry interactions with healthcare professionalsDemonstrated… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... designated team members.Support Investigations team by providing quality and compliance input for continuous improvement; and remediations.Lead quality driven… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Shift Schedule: ... a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulationsWear the appropriate PPE when working in manufacturing and… more
- Eisai, Inc (Pittsburgh, PA)
- …to relevant customer stakeholders in a compliant way.Monitor operating costs and compliance with territory budget.Seek out mentorship to learn and build key sales ... sales or related therapeutic area (Oncology sales experience preferred).Experience in hospital and large account sales, and documented history of successful sales… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the proper ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the proper… more
- Legend Biotech USA, Inc. (San Jose, CA)
- …among peers by consistent application and modeling of the appropriate compliance , behavior, and conductPerforms all administrative functions required for the ... healthcare professionals in accordance with Corporate, PhRMA, and OIG guidelinesStrict compliance with all regulatory agencies, state, and federal law is… more
- Eisai, Inc (El Paso, TX)
- …work cross-functionally while adhering to all of Eisai's ethics and compliance standards. Responsibilities: Responsible for sales and demand generation within ... patient pathway).Engage and influence key customers (including local and regional hospital systems) to sustain a strong organizational presence in the Alzheimer's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA ... site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good Manufacturing Practices (cGMP).Manage multiple and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities ... a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.Wear the appropriate PPE when working in manufacturing and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to ... business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to all applicable codes and regulations as required. Obtains… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, ... and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.Interacts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of cleanroom manufacturing, aseptic manufacturing ... assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other ... Management: Ability to identify, assess, and mitigate operational and compliance risks.Technology & Automation: Familiarity with modern manufacturing systems (MES,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …gaps in training requirements for OperationsSupports evaluation of appropriate compliance courses for OperationsPerforms training for new hiresOptimizes the ... to sustained right first-time executionServe as subject matter expert for Compliance & Training systemsKnowledge of LMS systemSupports the maintenance and reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …proper materials, parts and spare parts are identified and availableSupports team compliance to Lock Out/Tag Out programs, Hot Work permits, confined space entry ... assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide reduction in COGs, and increase throughput, capacity, and quality compliance .Work cross-functionally across the organization and interface with IT to drive ... assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide reduction in COGs, and increase throughput, capacity, and quality compliance .Work cross-functionally across Technical Operations and interface with IT to ... assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and… more
