- Novo Nordisk Inc. (Plainsboro, NJ)
- …corrective action(s)/preventative action(s) (CAPA) in connection with audit and/or inspection responses, and ensure proper implementation across various areas of ... work. Maintains up-to-date knowledge of relevant industry standards and regulations, and company policies and procedures relevant to his/her area of work Provides… 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. For ... or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line with company -wide policy and relevant regulatory requirementsCoordinate with broader DS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …using a risk-based approach to ensure the Audit Plans are aligned with the company 's strategy and objectives and adjust the plan as needed to support business ... functions, internal and external stakeholders to execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and… 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
- 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
- AUROBINDO (Durham, NC)
- …daily warehouse functions in /Warehouse, for this Generic Pharmaceutical Company .ResponsibilitiesReceive materials and conform the information in the packing slip ... that the scale is providing accurate information.Check and perform daily inspection of electric forklifts and electric hand trucks.Provide assistance in movement… more
- Eisai, Inc (Nutley, NJ)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is… more
- Merck & Co. (Durham, NC)
- …to the design, development and manufacturing of sterile products, making accessible our company 's next generation of Vaccines and Biologics. To this end, we strive ... of both drug substance and drug product, including product inspection , warehouse, utilities, and quality control laboratories.The Specialist, Operations will… more
- Merck & Co. (Rahway, NJ)
- …and Research Decision Sciences), a distinguished department within our company 's renowned Research and Development division, quantitative scientists, in partnership ... submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.The incumbent will be responsible for continuous improvement of… more
- Merck & Co. (Rahway, NJ)
- …(AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company 's Research Laboratories Division is seeking applicants for a Metrology and ... and external quality audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP)… more
- Merck & Co. (Rahway, NJ)
- …assembly equipment integrated processes such as ultrasonic welding and vision inspection systems.Author technical content of assembly process FMEAs to capture ... Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can...EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented,… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... patients. That's why we've been named the No. 1 company to work for in the biopharma industry in...therapy products is preferred.Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... patients. That's why we've been named the No. 1 company to work for in the biopharma industry in...of results and reporting that stands up to regulatory inspection .Demonstrated expert knowledge of scale-up principles with respect to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Guaranteed 8% 401K contribution ... plus individual company match option 14 weeks Paid Parental Leave Free...activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides technical… more
- Aequor (Hicksville, OH)
- …compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies and current Good Manufacturing Practices (cGMPs). ... lines and roles as necessary to maintain operational efficiency. Performs rework/re- inspection of components/finished goods with minimal conversation and focus on… more
- Eisai, Inc (Nutley, NJ)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... general enrollment figures to COL or leadership team as requestedContribute to inspection readiness, including, but not limited to, creating and updating various… more
- Novo Nordisk Inc. (Durham, NC)
- …Vision Insurance - effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & ... on site. May position oneself within confined spaces for inspection if required of the role. Ability to work...longer good enough to aspire to be the best company in the world. We need to aspire to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …perform close activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical conditions including ... is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only… more
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