- 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
- 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)
- …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)
- …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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …network and partners in commercialization and manufacturing in aspects of quality control , compliance, and strategic partnering. Primary Responsibilities: ... Guidelines, Pharmaceutical Microbiology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management {+ 5 more}Preferred Skills:… 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
- 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
- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …relationships with key leaders and stakeholders, namely External Manufacturing, Quality /Regulatory, Finance, Legal, and Shared Business Services, and other corporate ... Uses the Sourcing Management Process to manage assurance of supply, quality , service, cost, innovation and regulatory compliance within Global or International… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …expertise in support of GMP investigations, change controls, document control , process improvement, process validation and data management.Partners with Operational ... experience ownings SOPs, change controls, investigations, CAPAs and other quality system actions.Ability to engage all levels of the organization,… 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
