- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …existing equipment, processes, and instrumentation in accordance with science and risk-based validation (SRV). This role will provide input to project team members ... assistance is available for selected candidate. Relationships Reports to: Senior Manager - Facilities Engineering & Metrology. Number of subordinates with… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and ... analytical activities performed at CROs/CDMOs associated with method development, qualification/ validation , transfer and characterization for drug substance, drug product… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on ... system validation . Support computer system audits for review of SDLC...industry or similar.Familiarity with regulations governing software development and validation .Knowledge of Statistical Programming is preferred but not required.Knowledge… more
- Aequor (Thousand Oaks, CA)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Merck & Co. (Durham, NC)
- …in the coordination of resources and equipment pertaining to qualification/ validation activities supporting the vaccine expansion facility. Primary Responsibilities: ... that ensure required safety guidelines are followed.-Review and approve qualification/ validation documents for equipment and process (ie, IQ/OQ/PQ).Review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... the safety management, data management, communication, project management and validation plansParticipate in protocol and interim/final report preparation, shepherd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/QA of CDISC, SDTM domain output in accordance with… more
- Novo Nordisk Inc. (Durham, NC)
- …support is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution of ... of cGMP's is required Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility,… more
- Merck & Co. (North Wales, PA)
- …as monitoring, project management, safety management, data management and validation plans.Participate in protocol and interim/final report preparation, shepherd ... documents through the internal review process for approval, and submit to the internal repository.Coordinate internal/external meeting management and draft/review agenda/minutes.Ensure studies follow all non-interventional processes for informed consent,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the unitized budget against the needs, conducts rigorous negotiation of terms with validation of rates from service providers. Making sure the payment schedules are ... colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... projects to support the regulatory department as assigned.Provide support in software validation and migration activities relating to new or existing systems in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications ... for new equipmentDevelop control charts and statistical process controls for calibration standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all… more
- BioAgilytix (Boston, MA)
- …objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and ... technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator)independently creating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development, analysis files development, data surveillance review, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as ... analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This position is responsible for providing support to the Senior Manager and Director of Institutional Contracts by leading the team through the ... controls, and Sarbanes-Oxley regulations. Relationships Reports directly to the Senior Manager , Institutional Contracts. Interacts daily with others within the PCOR… more
