- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is...a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads… more
- Merck & Co. (Rahway, NJ)
- …junior analysts in core cyber threat intel tradecraft, analysis, and productionResponsible for Quality Assurance and Quality Control (QA/QC) of CTI ... Intelligence (CTI), to include intelligence collection, curation, management, analysis standards, quality control, and dissemination of finished products to a wide… more
- HEPCO, Inc. (Sayreville, NJ)
- …the Outreach staff, develop and monitor Key Performance Indicators (KPIs), and perform quality assurance reviews to ensure high standards across all projects. ... and annual targets Validate that projects meet program requirements and conduct quality assurance reviews Update and maintain all program manuals, guidelines,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Bachelor's degree or equivalent experience required 8+ years of operations, quality assurance , call center, compliance, project management, operations and/or ... lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated… more
- HEPCO, Inc. (Sayreville, NJ)
- …communication and meetings. Validate that projects meet program requirements and perform quality assurance reviews. Update manuals, guidelines, FAQs, and other ... customer, and vendor relationships with a focus on satisfaction. Provide quality assurance reviews for projects and ensure adherence to program guidelines.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or ComplianceExperience conducting internal ... in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality... Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP ... in the treatment of multiple myeloma.Legend Biotech is seeking Quality Project Management Specialist as part of the ...Quality Project Management Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP Committee. ... year' experience in pharmaceutical or biotechnology development functions or clinical quality assurance required Experience Qualifications Experience:10 or More… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reasoning skills in support of ongoing laboratory investigations.Collaborate with Quality Assurance , Manufacturing, Technical Operations, Engineering and ... will be assigned, as necessaryKey Relationships:Work in a collaborative setting with quality counterparts that include quality Assurance , Manufacturing… more
- Genmab (Plainsboro, NJ)
- …areas for improvement and drive process enhancements.Align GCDS efforts with Quality Assurance , Clinical Strategy, and other stakeholders.Address drug supply ... be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an planning perspective. Changes are a natural… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure ... to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among othersExperience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.Thorough knowledge and understanding of GMP data integrity standardsKnowledge of cGMP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role...is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a trusted partner,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Change Management process. Through careful coordination with stakeholders and consistent quality assurance , minimize the risk of changes, strive for ... uninterrupted implementation, and ensure a stable environment. Show an in-depth understanding of the global processes and implementation with regard to Change Management and related procedures- Training, Documentation and Support. Responsible for planning and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Thorough knowledge and understanding ... project execution and management, vendor management, data life cycle management, Quality events, remediation and improvement efforts of computerized systems for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Eclaro (Cranford, NJ)
- …across multiple sites including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance , Quality Control, Process Development, CMC, ... NJ. ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality , innovative, and affordable medicines that make a difference in the lives… more
- Eclaro (South Plainfield, NJ)
- …in preparation for review and approval Manage reference library metadata, including quality assurance of content delivered to the library, ensuring reference ... NJ. ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality , innovative, and affordable medicines that make a difference in the lives… more
