- Novo Nordisk Inc. (Plainsboro, NJ)
- …Interact closely with NNI Patient Safety and NAO Quality Audits & Inspections . External relationships include interactions with NNI vendors involved in the NNI ... and or provides support to audits and Health Authority inspections , including readiness activities, to ensure internal/external compliance with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections and execute against these metrics consistently. Provide inspection management support regarding compliance concerns identified during internal systems ... Medicines and Companion Diagnostic productsProven experience with Health Authority Inspections , (eg, FDA, HPFB, MHRA and other European regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …post marketing stakeholders for key Health Authority pre-approval and sponsor-monitor inspections ; provide inspection management support and follow-up activities ... audit program and effective CAPA management resulting from audits, health authority inspections across the organization and affiliates as appropriate for the area of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections ... GRA processes and ways of workingDrive activities required for GRA to be inspection ready, and support addressing any observations or findings that may result from… more
- Insmed Incorporated (San Diego, CA)
- …a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a strategic audit plan ... gene therapy products is preferred.Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections .Lead facility ... horizon to prepare for tomorrowTrack record of successfully leading audits and inspections (FDA, EMA, etc.)An ability to build strong partnerships and effectively… more
- Aequor (East Syracuse, NY)
- …standards, extended characterization, and product stability/ shelf-life.Support regulatory inspections , third-party audits, and customer audits through participating ... in inspection readiness and addressing inspectional findings.Perform routine laboratory activities including sample management, instrument maintenance and… more
- Repligen (Hopkinton, IA)
- …role is responsible for inspecting, auditing and reporting on in-process and final inspection of single use assembly parts at the Hopkinton, MA production facility, ... customer quality standards.ResponsibilitiesThe QC Inspector I will be responsible for:Conduct inspection of single use assembly designs of customers and approves or… more
- Eisai, Inc (Nutley, NJ)
- …North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is ... clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as required to assure compliance with PV agreements.Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies ... cited in audit/ inspections . Manage the implementation of effective corrective and preventative action PV Agreements and Contracts: Manages PVAs/SDEAs and maintains… more
- Merck & Co. (Durham, NC)
- …Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection MachinesThe ability to satisfactorily perform all types of industrial… more
- Repligen (Clifton Park, NY)
- …for area cleanlinessread and understand quality and inspection documentsread/understand molding drawingsbasic math competencyunderstanding of measuring ... supplies or manufacturing experience is a huge plus.Quality control or inspection experience is highly desirablePrevious experience working in a Cleanroom… more
- Merck & Co. (Durham, NC)
- …Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection MachinesThe ability to satisfactorily perform all types of industrial… more
- Aequor (Davie, FL)
- …as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including ... inspection ), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes. Operate motor vehicles or heavy equipment. WORKING… more
- Aequor (Thousand Oaks, CA)
- …the ability to lift 50&plus pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, though ... overtime. Under general supervision, this position is responsible for sampling and inspection of raw materials and components and for performing Quality review of… more
- Repligen (Hopkinton, IA)
- …performing basic and complex assembly techniques, executing detailed visual inspections , operating manual and automated machinery, and completing packaging and ... follow standard operating procedures of varying complexityPerform detailed visual inspections on in-process and finished productsPackage and label finished… more
- Eisai, Inc (Raleigh, NC)
- …responsible for executing core quality assurance functions, supporting regulatory inspections , and collaborating with internal and external stakeholders to resolve ... on product quality. \tActing as a Subject Matter Expert (SME) during regulatory inspections in assigned area(s) of responsibility.This role requires a high level of… more
- AUROBINDO (Durham, NC)
- …that the scale is providing accurate information.Check and perform daily inspection of electric forklifts and electric hand trucks.Provide assistance in movement ... and dispensing team.Maintain record keeping of all material movement within the warehouse. Inspection and loading of finished products shipments.To drive the truck to… more
- Merck & Co. (Rahway, NJ)
- …sections, and support response to questions and pre-approval inspections from a product development standpointStakeholder Collaboration and Communication:Secure ... aligning with the company's divisional and local site procedures.Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …utilization of the warehouse space. This individual will assist in regulatory inspections , perform safety and quality audits, and answer relevant questions about ... optimization and efficient utilization of the warehouse space.Assist in regulatory inspections , perform safety and quality audits, and answer relevant questions… more
