- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ledger, Travel Management, Master Data, Procure to Pay, Invoice to Pay, Project Systems , Taxes, Vertex Application Support , Electronic Banking, Vertex ... Perform system customization and configuration work as needed to support new and existing functionality. Responsible for the development of the Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Aequor (Bothell, WA)
- …and process automation in addition to prior manufacturing enterprise systems support . REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:Comprehensive ... applications including their software development life cycle activities and technical support .Provide ownership of assets and utilize Client systems to… more
- Merck & Co. (Durham, NC)
- … System Use and Administrative SOPs (including sufficiently detailed electronic data review/audit trail review instructions for users), disaster recovery plans, ... documentary evidence to verify that compliance activities related to computerized systems are in place and effective. Support regulatory inspection and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU ... assigned by management and continue to develop professionally.Strong proficiency utilizing electronic Quality Systems per curriculum.Utilizes tools within MS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …status reports, and coordinate with cross-functional departments. Support Document Management system users with workflow handling and electronic system ... the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This… more
- Merck & Co. (Durham, NC)
- …or startup methodologies for introduction/launch of a cGMP drug substanceExperience with electronic systems :- SAP, ProCal, DeltaV and KneatExperience with Kaye ... responsible for providing cycle development and PQ for equipment and systems supporting bulk biological processes (ie Sterile Supply, Adjuvant Manufacturing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are...individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant and with the… more
- Genmab (Plainsboro, NJ)
- …submission-ready labeling documents; Maintains and tracks labeling documents in the electronic system as appropriate.Participates in the development and ... labeling and labeling trends, proposing content as relevant to support optimized labeling. Ensure proper development, review, approval, implementation, maintenance,… more
- Aequor (Bothell, WA)
- …team, and to significantly contribute to Oncology's mission. Responsibilities: Support protein material generation activities, including both purification and ... corrective action and resolution. Prepare buffer and media solutions to support material generation and process development runs. Perform equipment (eg, bioreactor,… more
- Merck & Co. (Durham, NC)
- …production and manufacturing operations. The individual in this position will support the vaccine manufacturing process through hands on processing activities.- Key ... are not limited to: Works collaboratively with all operations and support personnel, performing manual and automated processing of vaccine manufacturing equipment,… more
- Everglades Equipment Group (St. Cloud, FL)
- …Certification in automotive air-conditioning Read hydraulic schematics and diagnose hydraulic system faults Read electrical schematics and diagnose electronic ... basic mechanical to complex technical diagnostics of modern computerized systems . Must be able to provide own basic tool...basic tool kit. Must be able to navigate product support software, computer programs for work order maintenance and… more
- Merck & Co. (Durham, NC)
- …laboratories.The Associate Specialist, Technical Operations will be responsible for providing technical support as part of one of the drug substance or drug product ... when possible.Assist with the design, authoring and execution of protocols in support of the technical transfer using the Technical Operations laboratory facilities… more
- Merck & Co. (Rahway, NJ)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbant is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key… more
- Aequor (Newbury Park, CA)
- …regulatory requirements. To manage and execute of the preparation, delivery and electronic archiving of documentation for inclusion in US regulatory submissions To ... Affairs Senior Associate position are: Assist US Regulatory Lead to support regional regulatory activities (eg IND submissions and agency meetings) Provide… more
- PlanIT Group (Washington, DC)
- Systems Engineer What You Will Do : Recruiting System Engineers to outwit complexity and be a part of our fast-growing litigation and investigation support ... Relativity, and Enterprise Vault, performing engineer and administrator services in support of electronic discovery including the operations and maintenance… more
- Merck & Co. (Durham, NC)
- …start-up testing in new laboratories using principles of our Production Systems , Lean Laboratories, and GMP requirements.- GENERAL PROFILE: Work cross-functionally ... requirements toward analytical testingCapability to function effectively within an automated/ electronic laboratory environment. - BUSINESS EXPERTISE: Understands the fundamental… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Regulatory Inspections for QC.Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of ... management or leadership experience is required.Experience working with Quality systems is required.Experience with quality support in clinical/commercial… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key… more
- Uline (Pleasant Prairie, WI)
- …guides, marketing materials and documentation. Minimum Requirements Bachelor's degree in information systems , IT or a related field. Prior Electronic Data ... Associate Electronic Data Interchange Analyst Corporate Headquarters 12575 Uline...12575 Uline Drive, Pleasant Prairie, WI 53158 Is making systems speak seamlessly your specialty? Are collaboration and customer… more
