- Hovione (Cranbury, NJ)
- …be responsible to: This position is for the 3rd shift: 9:30pm- 6:00am Defines and implements quality control techniques in order to verify the quality of raw ... to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a biological and/or pharmaceutical industry is required.Experience in a Quality Control setting is preferred.Experience with processing samples in ... is seeking QC Analyst I as part of the Quality team based in Raritan, NJ. Role OverviewThe QC...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …demonstrated passion for creating new medicines.Experience with Engineering, Operations, Quality Control and Facilities Management.Experience in effectively ... minimize downtime.Collaborate with cross-functional teams including Facilities, Finance, HR, Quality and Operations to ensure engineering support broader organizational… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Genscript USA Inc. (Piscataway, NJ)
- …verification and turnover documentation are complete. Support construction scheduling, cost control , and quality management, in collaboration with the Senior ... leadership will directly influence operational resilience, response time, and long-term cost control . This is a full-time role based onsite in Piscataway, NJ. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …management systems (CMMS)Building Automation System (BAS) and Environmental Monitoring System (EMS) Quality Investigation / Change Control System / Documentation ... to ensure the facility is in a state of control and update / communicate with all teams with...the team.Partner and managing relationships with contractors to ensure quality of work and compliance with all company policies… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological ... and procedures in a GMP environment including microbiology data review and quality procedures.This position is based at the Rahway, New Jersey site.Primary… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological ... and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the Rahway, New Jersey site.Primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high… more
- Merck & Co. (Rahway, NJ)
- …Industrial Hygiene, Innovation, Inventory Management, Management Process, Manufacturing Quality Control , People Management, Pharmaceutical Biology, ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of ... or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks… more
- Merck & Co. (Rahway, NJ)
- …clinical and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and ... Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study progress.May… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sops. Lead the maintenance of signal tool and support tasks of change control , training material update, and end user support or process enhancement. In ... as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality assessments).This… more
- Merck & Co. (Rahway, NJ)
- …company clinical trials and assay metadata generated from these collections.Embed automated quality control checks and validation rules directly into data ... pipelines, ensuring our data assets meet the highest standards for compliance and integrity.Support teams with reports of biomarker information using various query and database integration tools.Leverage the Microsoft Power Platform to eliminate manual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment ... not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr. Manager, Strategic Initiatives to support various strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturingMaintenance and facilities managementComputerized maintenance management systems (CMMS) Quality Management knowledge, including Change control , ... programs, facility emergency response plans and other required safety programs. Supports Quality driven initiatives related to facilities work such as change … more
- Merck & Co. (Rahway, NJ)
- …development for large-scale recombinant protein expression in mammalian systemsKnowledge of Quality by Design, Process Characterization and Control Strategy ... developmentPRD #eligibleforerpRequired Skills: Biological Manufacturing, Biologics, Bioprocessing, Cell Cultures, Chromatographic Separations, Communication, Downstream Processing, Molecular Biology Techniques, Process Development (PD), Process Optimization,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for site's Strategic Initiatives Team.Defines the interdependent deliverables and ensures that quality , risk, cost, time are managed within the overall approved plan ... implementation in a GMP Commercial Facility.Experience with Asset Change Control , Process/System Improvement, Asset Lifecycle activities/documentation.Excellent knowledge of project… more
- Merck & Co. (Rahway, NJ)
- …CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions for products that may include respiratory/ inhalation, peptide, ... Regulatory Policy and the Head of CMC External Advocacy in Manufacturing Quality , to monitor changes in regulatory environment with potential strategic impact and… more
- Merck & Co. (Rahway, NJ)
- …As a result, VCM Product Leaders have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity of supply, ... product enhancements, cross-product considerations, process and method technical changes, robustness/ quality / productivity projects. Manage product supply risk through Integrated… more
