- Aequor (Swiftwater, MN)
- …of validation and development studies. The position will support the Validation Specialist /execution by obtaining and compiling data into a data pack ... coordinator is a critical role in the execution of validation and development studies. Failure to comply with the...meet the expected completion date 2. Communication with the specialist /executor and Group Lead is essential if unanticipated delays… more
- Merck & Co. (Rahway, NJ)
- …Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation .-Our Global Engineering Solutions executes a wide variety of capital ... for Life" goal. The Global Engineering Solutions group is seeking an Senior Specialist of Engineering to manage large capital projects independently or a series of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking CQV Specialist (Contractor) as part of the Technical Operations team based in Raritan, ... OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded Specialist , Sterility Assurance that can help drive our Strategic Operating Priorities.Invent - Pursue ... and Standards will Continue to Guide Us as We Take on New ChallengesThe Specialist , Sterility Assurance will serve as a member of the Sterility Assurance team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA, Document Control Specialist (1st Shift) as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Document Control Specialist (1st shift) role is an exempt level position with responsibilities for supporting the document management process… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and ... reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports ... Participates in Regulatory Inspections Other duties as assigned Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and analyzes contract terms and conditions of contracts. Ensures data in validation and rebate systems reflect the contract terms for accurate processing Reviews ... data received is loaded accurately and in a timely manner prior to data validation . Coordinates with external source for loading and scrubbing of rebate claims data… more
- Aequor (Northborough, MA)
- …in-house product specifications and market regulations Reviewing and approving validation protocols and change controls Authoring, revising and reviewing SOP's ... through Veeva System Utilizing Veeva to complete investigation of deviations, CAPAs and Change Controls Supporting compliance walkthroughs, Participate in internal audits Participate in QA audit readiness program as well as assist and participate in external… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …tracking, follow-up, and reporting / trending Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports. ... Other duties as assigned Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities… more
