- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... + Maintain a clean and safe work-space + Maintain laboratory notebook and/or computer files (ie LIMS) according to standard, accepted practices + Participate in… more
- Mentor Technical Group (Monroe, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... and routine troubleshooting. + Collaborate with Quality Assurance, Engineering, and Validation teams to support production and resolve deviations. + Adhere strictly… more
- Fujifilm (Raleigh, NC)
- …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
- Cambrex High Point (High Point, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... + Maintain a clean and safe work-space + Maintain laboratory notebook and/or computer files (ie LIMS) according to standard, accepted practices + Participate in… more
- ThermoFisher Scientific (Greenville, NC)
- …sites. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess ... detail, process and prioritize sensitive complex information + Proficiency in basic computer applications + Fluent in spoken and written English + Excellent… more
- Herbalife (Winston Salem, NC)
- …requiring the development of capital requests, installation, acceptance testing, validation support, maintenance plans, training materials and operations technical ... working knowledge of Programmable Logic Controllers, operator interface devices, industrial computer products, distributed I/O and wiring systems and how to apply… more
- Sumitomo Pharma (Morrisville, NC)
- …for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity. + Performing inspection and disposition of ... Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents. + Experience in tissue and cell-based… more
- Cardinal Health (Raleigh, NC)
- …(California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV ( Computer System Validation ), DSCSA(Drug Supply Chain Security Act), as well ... as relevant governance frameworks to drive compliance to those regulatory requirements such as NIST, HITRUST, SOC 2, ISO, COBIT, ITIL, etc., while working with members of the Information Security and Risk Management team as well as stakeholders from Finance,… more
- Pfizer (Rocky Mount, NC)
- …(or equivalent) and 10 years ofrelevant experience. + Proficiency in user-level computer knowledge for completing documentation and tools such as AutoCAD, Excel, ... Solid understanding of Current Good Manufacturing Practices and facility/equipment validation requirements + Technical expertise in pharmaceutical processing equipment… more
- IQVIA (Durham, NC)
- …activities for a molecule (writing specification for ADaM, ADaM/TLF programming & validation for both Safety & efficacy), primarily involving legacy data. + Develop, ... Sciences or specific project teams. **Qualifications:** + Bachelor's degree in computer science, math, statistics, biology, pharmacology, or related. + 8+ years'… more