- Formation Bio (New York, NY)
- …vendor relationships and governance, holding external partners to high standards of quality , cost control , and on-time deliverables. Serve as the Operations ... Lead for clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and implement operational strategies for programs and clinical studies. Collaborate with cross-functional… more
- Merck & Co. (Rahway, NJ)
- …Drug Product Development, Estimation and Planning, General Safety, Manufacturing Quality Control , Mechanical Troubleshooting, Pharmaceutical Process Development, ... Control Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance, Regulatory Issues,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Manufacturing Operations, Quality Control , and Operations Technical Support.RequirementsA minimum of a ... of multiple myeloma.Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Change … more
- Merck & Co. (Rahway, NJ)
- …microscopy and chromatography.Collaborate with cross-functional teams, including research, development, quality control , and regulatory affairs, to ensure ... Leadership, Pharmaceutical Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory… more
- Merck & Co. (Rahway, NJ)
- …Innovation, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process Improvements, ... will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …FDA Regulations, Good Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control , Master Batch Records, Material Selection, ... closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training team. This individual will be responsible for performing training activities for Quality Control Microbiology team members who support cGMP Clinical and ... temporary coverage as needed.Key ResponsibilitiesLead, coach, and deliver trainings for the Quality Control Microbiology team and Operations team (as needed).Be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to ... fieldSolid understanding of regulatory requirements, policies and guidelinesExperience with Quality Control document reviews and regulatory inspection… 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)
- …and commercial support. The Quality Compliance scope includes working on Quality related sub-teams such as change control sub-teams and investigational ... into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and… 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 aseptic processing in ... myeloma.Legend Biotech is seeking QC Investigations Specialist II as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Investigations Specialist is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …setting with Quality , Manufacturing Operations, Facilities & Engineering Quality Control , Operations Technical Support, Supply Chain and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… 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)
- …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)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… 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)
- …closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success and performance ... PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.- Able to report… more
- Merck & Co. (Rahway, NJ)
- …tables, graphics, listings)Demonstrated success in the assurance of deliverable quality and process compliance. Good working knowledge of reporting processes ... working with coding systems such ICD-9, ICD-10, CPT, NDCExperience in version control tools (eg, git, Github)Experience with Common Data Model (CDM)Familiarity with… more
- Merck & Co. (Rahway, NJ)
- …workflows.- - Required Skills and Experience: Knowledge of manufacturing, testing, quality , and supply chain processes from late clinical development through ... CMC regulatory content Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform… more
- Merck & Co. (Rahway, NJ)
- …and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be expected to lead ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
