- Sumitomo Pharma (Raleigh, NC)
- …+ 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
- GRAIL (Raleigh, NC)
- …power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's ... work with other maintenance and technical trades, contractors, engineers, metrology, validation , and quality to help keep these systems operational while adhering… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …proceed with proper decision making + Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including ... scheduled or required to maintain systems in a validated state + Perform computer applications + Perform other duties as assigned by Management Education, Skills, &… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... systems (in a regulated environment within the last 6 years preferred). + Basic Computer Skills required; must be experienced and proficient in the use of Windows… more
- ThermoFisher Scientific (Greenville, NC)
- …systems. This position is essential for maintaining a culture of compliance with FDA , EMA, and other global health authority expectations related to GMP, GDP, and ... + Works with QC laboratories, manufacturing, QA, IT, and validation teams. + Ensures tasks and documentation are aligned...periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and improves procedures and Preventative Maintenance Activities. a. Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... equipment (in a cGMP environment within the last 6 years desired). 3. Basic Computer Skills required; must be experienced and proficient in the use of: Email and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …equipment reliability and efficiency + Ensure all maintenance activities comply with FDA regulations, GMP, ISO standards, and safety protocols + Utilize and maintain ... systems desired. + Proficiency in machining, welding, and fabricating a plus. + Basic Computer Skills required; must be experienced and proficient in the use of: + +… more
- ThermoFisher Scientific (Greenville, NC)
- …fills). + Experience with pharmaceutical industry technology, especially from a validation , technical or laboratory role would be useful. **Knowledge, Skills, ... sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. +...periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged… more
- Herbalife (Winston Salem, NC)
- …Manufacturing, Planning, Product Development, QC, Safety, Sanitation, Sourcing, Training and Validation as it relates to Facilities and Engineering operation at the ... collaborative working relationship with internal customers, and contract vendors.* Proficient with computer applications * Must have a valid Driver's License with a… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …+ Work with other departments and assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation ... ability to accurately interpret technical documentation are critical + Perform computer applications including learning and execution of SAP transactions + Leverage… more