- Insmed Incorporated (NJ)
- …safety and product quality. The position requires proficiencies in key Quality Systems Process such as Change Control , Deviation, CAPA, Supplier Quality, ... Internal/External Audit, Quality Complaints and Production Process Control .What You'll Do: Provide Quality Assurance oversight for GxP computerized systems… more
- Insmed Incorporated (NJ)
- …and evidence gathering. Change Control Coordination: Support the Change Advisory Board (CAB) review process by preparing documentation, organizing ... and tracking change requests.Documentation & Process Improvement: Help develop and update IT operational procedures to maintain efficiency and compliance.Data… more
- Merck & Co. (Rahway, NJ)
- …planning, integrated risk management, cost of goods projections, post approval change management and lifecycle strategies for their product(s).- As a result, ... with senior level stakeholders for Small Molecule products across Global Pharmaceutical Operations (GPO) and the Manufacturing Organization.- As the VCMT leader,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … process platform changes/improvements in a global manufacturing network and change management process .Candidate must have extensive experience in Cell ... a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop...analytics scope in support of the approved Carvykti commercial process . At a technical level, the candidate will be… more
- WuXi AppTec (Middletown, DE)
- …as an equipment or process engineer with process control systems and troubleshooting of pharmaceutical manufacturing processes and packaging equipment. ... of engineering principles, process design and optimization, quality control , pharmaceutical manufacturing technologies, equipment, and relevant software.… more
- BioAgilytix (Durham, NC)
- …checks, and setting up clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting ... turning those clean, validated data streams into the audit-ready files our pharmaceutical sponsors need on tight deadlines. You'll harmonize results from multiple… more
- Merck & Co. (Rahway, NJ)
- …Cognitive Psychology, Conflict Resolution, Cross-Functional Teamwork, Customer-Focused, Design Control Process , Ergonomics Consulting, Human Factor Engineering, ... to enhance HF capabilities and influence industry standards.Act as a change catalyst, driving execution excellence and continuous improvement in HF… more
- Insmed Incorporated (NJ)
- …development programs.What You'll Do: Accountable for reviewing and approving all CMC change control documents and disposition of proposed changes and scheduling ... degree is a plus.Minimum of 7 years experience within the biotechnology or pharmaceutical industry and development knowledge of different dosage forms in US and… more
- Aequor (Bothell, WA)
- …debug and document software applications. Commit changes to git-based source version control . - Consult with users and stakeholders to ensure that requirements are ... software development work experience. - Prior experience within the pharmaceutical , healthcare, or a related life sciences industry. -...and thrive in an evolving environment. - Adapt to change quickly and adjust work accordingly in a positive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …through full implementation in a GMP Commercial Facility.Experience with Asset Change Control , Process /System Improvement, Asset Lifecycle ... entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize… more
