- ITG Brands (NC)
- …needs. + Coordinatequalification/validationtesting + Maintains project data base by writing computer programs, entering and backing up data + Lead the development ... regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations &… more
- Teleflex (Morrisville, NC)
- …for Application, ensuring adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a best-in-class, ... * Bachelor's degree in a technical field such as Computer Science or Information Systems (a combination of education...objectives * Strong communication skills * Experience in an FDA regulated environment preferred * Project Management and/or Lean… 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)
- …+ 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 +… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …making13. Work with other departments and assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including ... or required to maintain systems in a validated state14. Perform computer applications including learning and execution of SAP transactions15. Communicate with… 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
- GRAIL (Durham, 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
- 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
- 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
- Sumitomo Pharma (Raleigh, NC)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
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