- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main point of ... a global and regional level as required.Support audit and inspection readiness activities as a subject matter expert. This...individual will be accountable for maintaining a state of inspection readiness and in turn, act as key representer… more
- Merck & Co. (Rahway, NJ)
- …performance and adherence to safety protocols.Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an ... electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with… more
- Merck & Co. (Rahway, NJ)
- …to cross-train in other parts of the process including thaw, formulation, visual inspection , and sterile supply. These individuals are expected to partner with, and ... performance and adherence to safety protocols.Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …invoices, including investigator grants and pass through costs.- Quality and inspection readiness-Support inspection readiness and quality initiatives pertaining ... with inspector(s) to address study inquiries throughout course of HA inspection -Ensure trial master file is complete and accurate for assigned stud(ies).-Ensure… more
- Eisai, Inc (NJ)
- …the Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and innovation.The position ... Directs global outsourcing team and oversees collation of documentation to ensure inspection readiness on a regional Provides guidance on outsourcing SOPs and work… more
- Repligen (Rancho Dominguez, CA)
- …and that adequate procedures and work instructions are in place.Preparing quality/ inspection plans, procedures and instructions, and product / raw materials ... Ensures documentation contains the necessary criteria and provisions for effective inspection and testing.Compiling and analyze data related to quality and… more
- Repligen (Clifton Park, NY)
- …tubing according to work instructions, batch records, and quality standards.Perform inspection of components for defects, damage, or contamination prior to ... and manual dexterity for handling small parts.Ability to perform detailed visual inspection tasks.Ability to stand for extended periods while working in a cleanroom… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …In addition, this role will support Compliance initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …LIMs to align physical quantities of samples in freezers/refrigeratorsPeriodic inspection and consolidation of retainsDocument and perform sample management related ... and guidelinesExperience with Quality Control document reviews and regulatory inspection processesWorking knowledge of Quality systemsExperience in management of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsDrive continuous improvement initiatives leveraging Lean/Six Sigma methodologies.Maintain inspection readiness and contribute to regulatory inspection ... support.In depth understanding of S&OP, production planning and materials management processesAn ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environmentAbility to… more
