- Sumitomo Pharma (Annapolis, MD)
- …warehouse environment. + Ensure that all SAP solutions adhere to **GXP, FDA , and other regulatory requirements** applicable to the pharmaceutical industry, including ... validation and documentation standards. **Team Management & Governance** +...& Technical Skills** + Bachelor's or Master's degree in Computer Science, Information Technology, Engineering, or a related field.… more
- Fujifilm (Annapolis, MD)
- …technical aspects of Synapse product HL7 integration, from install, configure and validation phases through product go-live, for all Synapse MI products. HL7 IE's ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Guidehouse (Hanover, MD)
- …cleaning, data transfers, data quality control, data integration and validation , data analysis and report package preparation, statistical simulation, statistical ... biology, biochemistry, microbiology or similar), or physical science (engineering, physics, computer science, or similar) + **OR** **Post graduate degree in**… more
- Catalent Pharma Solutions (Harmans, MD)
- …filtration skids, freezers, etc. + Participates in facility expansion and validation projects. + Recommends parts/supply purchases for equipment within the ... of Phase I/II bulk Biologics. + Basic math and computer skills (WORD, EXCEL) and must be familiar with...and repairing equipment. + Experience in working in an FDA regulated, cleanroom environment that requires full gowning (Tyvek… more
- United Therapeutics (Silver Spring, MD)
- …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... departmental procurement and inventory programs + Support Facilities, Operations, Quality, Validation , and R&D across multiple sites with coordination needs. Prepare… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …requirements and sound understanding of the pertinent Quality System/Regulations. + Computer skills in word processing, spreadsheets and a statistical package ... + Moderate knowledge and understanding of the Food and Drug Administration ( FDA ) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000… more
- Sumitomo Pharma (Annapolis, MD)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- TestPros (MD)
- …Analysis, Cyber Security, NIST SP 800-171 Assessment and Compliance, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 ... and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and… more
- TestPros (MD)
- …Analysis, Cyber Security, NIST SP 800-171 Assessment and Compliance, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 ... and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and… more