- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness,… more
- Cipla (Central Islip, NY)
- …manner to ensure avoidance of all actual and potential conflicts of interest Risk management Minimize impact of supplier shortages by proactively identifying and ... relationships, negotiating favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success in this… more
- Merck & Co. (Durham, NC)
- …Professional Integrity, Project Management , Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Operations, Risk Assessments {+ 5 ... as formulation, filling, lyophilization, or automated inspection processesFamiliarity with process risk assessment tools, Quality by Design principles, and… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company ... review.Strive to reduce non-conformances in supported areas by proactively driving compliance .Support Investigations team by providing quality and compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …accuracy; identify necessary SME reviewers such as Quality , Safety, Compliance , IT based on business understanding and risk assessment; collaborate ... base will include contract owners and requesters, SME reviewers in Legal, Safety, Quality , Compliance , Data Privacy, IT, etc. Will interact with third-party… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams in trouble shooting and resolving complex scientific / technical problems.Evaluates quality processes and system standards to ensure compliance with ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell… more
- Merck & Co. (Rahway, NJ)
- …to go live with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level ... collaborate regularly with upstream operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Preventative Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues ... an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend… more
