- Cook Medical (West Lafayette, IN)
- …+ Ensure data quality through edit checks, form logic, and data validation . + Manage user and site administration, including setting up roles, permissions, ... escalation of study-specific functional issues, tool/vendor issues, testing and validation needs, enhancement requirements, and custom functions. Collaboration: +… more
- Tecomet (Warsaw, IN)
- …simulated use testing etc). + Assist in the creation of product process validation plans and testing. + Assist other design engineers, manufacturing engineering and ... + Project Management + Three-Dimensional Parametric Solid Modeling + FDA QSR and ISO 13485 quality standards + Quality...and statistical evaluation + Process development and improvement + Computer skills, including 3-D CAD , Word, Excel, and… more
- Lilly (Indianapolis, IN)
- …related to packaging processes and equipment + 2+ years experience in GMPs and computer systems validation (CSV) + Experience in serialization and full track and ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP, SAP+) and… more
- Novo Nordisk (Bloomington, IN)
- …verification + Accountable for completion of qPCR/PCR method development, qualification, validation , and execution + Accountable for daily operations of the site's ... standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking,...with company SOP's, specifications, as well as cGMP, ICH, FDA , EMA regulations or guidelines + Leads regulatory and… more
- Lilly (Indianapolis, IN)
- …processes and equipment + 1+ years of experience in GMPs and computer systems validation (CSV) **Additional Skills/Preferences:** + Experience in serialization ... with stakeholders + Familiarity with industry standards such as GS1 and FDA DSCSA regulations System integration with enterprise resource planning (ERP, SAP+) and… more
- Sumitomo Pharma (Indianapolis, IN)
- …policies, processes, and systems to enable accurate and timely data capture, validation , and reporting + Oversee and directly manage the collection, integration, and ... + Strong knowledge of regulations and guidance related to FDA , OIG, CMS, FTC, and PhRMA + Strong knowledge...communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America… more
- Cognizant (Indianapolis, IN)
- …delivery with benefits delivered as committed required. + Experience in GxP systems, Computer System Validation , and consistent track record in the support of ... FDA regulated systems and business required. + Strong interpersonal skills required. Excellent communication, networking, and influencing skills including the… more
- Novo Nordisk (Bloomington, IN)
- …Inspection & Packaging working cross-functionally with support groups including Validation , Quality Assurance, Engineering, and Manufacturing Science & Technology + ... Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.… more
- Lilly (Indianapolis, IN)
- …key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. Portfolio Delivery + ... of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, Privacy knowledge, etc.) to study database building… more
Recent Jobs
-
E/M Multi-Specialty Coder - Coder II (Remote)
- Cedars-Sinai (Los Angeles, CA)
-
Associate Director, Validation and Engineering
- Catalent Pharma Solutions (Harmans, MD)