- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Investigations Lead (1st or 2nd shifts) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Investigation Supervisor as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe CAR -T Investigation Supervisor will work with the investigation ... team to help identify true root cause of investigations and assess product quality impact. This individual will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Supervisor (2nd shift) as part of the Quality team based in ... Raritan, NJ. Role OverviewThe QA Investigations Supervisor has the responsibilities for providing quality oversight over the production of a personalized cell… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …other operational problems as assigned. This position is responsible for leading investigations to ensure the written investigation report contains the technical ... deviation reportsProvides consistent direction and ensures timely completion of deviation investigations to ensure ongoing consistency for investigation reports… more
- Tris Pharma (Monmouth Junction, NJ)
- …Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Merck & Co. (Durham, NC)
- …ensure optimized product quality and manufacturing processes, regulatory compliance , employee and environmental safety, integration of new/existing technologies, ... execution of deviation management activities, including coaching staff through incident/ investigation authoring, QN review/approval, speaking to QNs pulled for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/ internal audits.Collaborate with site ... reagents.Strive to reduce non-conformances in supported areas by proactively driving compliance .Support Investigations team by providing quality and … more
- Merck & Co. (Rahway, NJ)
- …the Company's pipeline. This role may support facility operations, support compliance investigations /change management, author GMP documentation and manage/lead ... molecule drug substance and/or biologics process development.Experience in supporting compliance investigations and change management.Familiarity with US and… more
- Merck & Co. (Rahway, NJ)
- …our Company's HR teams and compliance functions in audits and internal investigations .Provide training to HR and line management teams on employment ... wage and hour, HR practices, performance management, leave management, investigations , terminations, restructurings and labor relations.Handle and defend the company… more
- Merck & Co. (Rahway, NJ)
- …will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating ... in risk assessments, deviation investigations , and Good Documentation Practices (GDPs).-A high level of innovation, creativity, and self-initiative along with the… more
- Merck & Co. (Durham, NC)
- …of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create ... This position is accountable for performing lot release testing in compliance with standard operating procedures, safety, and cGMP regulations. Primary duties… more
- Merck & Co. (Rahway, NJ)
- …molecule drug substance and/or biologics process development.Experience in supporting compliance investigations and change management.Experience in Process ... MACS Process Supervisor will assist on daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements to meet MACS objectives… more
- Daiichi Sankyo, Inc. (Boston, MA)
- …responsibilities in a compliant/ethical manner. Handle PHI appropriately by ensuring compliance with HIPPA regulations, laws, and internal company ... of DSI products. ADFR's provide strategic coverage/reimbursement leadership and support to internal DSI leadership and Care Team's to which their geographies align.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …absence and accommodations, background checks and other pre-employment screenings, internal investigations , restrictive covenants, policy development, drafting, ... review and implementation, and restructures); employee benefits (design, implementation, compliance , and governance of ERISA health and welfare plans, pension plans,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Reports to Associate Director, EHS at US headquarters in MA. Internal relationships include working with Facility Personnel, Research Scientists, Research Associates ... Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on laboratories as well… more
- Merck & Co. (Rahway, NJ)
- …pilot plant environment.Experience reviewing and approving GxP documentation, quality investigations and change management.Extensive knowledge and experience of drug ... progress of growth.Familiarity with US and EU GMP and Safety compliance regulations.Desire and willingness to learn, contribute and lead through independent… more
- Daiichi Sankyo, Inc. (Seattle, WA)
- …responsibilities in a compliant/ethical manner. Handles PHI appropriately by ensuring compliance with HIPPA regulations, laws and internal company ... of DSI products. ADFR's provide strategic coverage/reimbursement leadership and support to internal DSI leadership and Care Team's to which their geographies align.… more
- Merck & Co. (Durham, NC)
- …and approve automation documents, preventive maintenance, and SOPs to ensure compliance with Good Manufacturing Practices and safety.Leads investigations of ... of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …assistance is available for selected candidate. Relationships Reports to: Manager, Investigations & Compliance Number of subordinates with direct/indirect ... in collaboration with NNUSBPI SME's & process groups Develops & maintains internal & external stakeholder relationships Ensures projects are completed with metrics &… more
- Insmed Incorporated (San Diego, CA)
- …LIMS. Escalate out of trend observations and support associated investigations , including: temperature excursion assessments, client and regulatory requests, and ... Manufacturing and CMOs, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.Create, maintain, and… more
