- 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 ... to detail with GMP experience including knowledge of change control, validation and commissioning process desired. 6. Ability to work successfully autonomously… 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 ... to detail and GMP experience (including knowledge of change control, validation , and commissioning processes) desired. 8. Ability to work successfully autonomously… more
- ThermoFisher Scientific (Greenville, NC)
- …fills). + Experience with pharmaceutical industry technology, especially from a validation , technical or laboratory role would be useful. **Knowledge, Skills, ... build/refurbishment of sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. + Strong investigative skills,… more
- J&J Family of Companies (Wilson, NC)
- …lifecycle management including Analytical Instrument Qualification (AIQ) and Computer System Validation (CSV), among others. + Perform budget support as the point ... + Deep understanding and experience in application of global regulatory ( FDA , EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing… 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 ... experience or similar job experience* 5+ years' experience in cGMP, FDA regulatory requirements* Experience supporting the development/tracking of project scope,… more
- Teleflex (Morrisville, NC)
- …support activities in product and process design such as design verification, design validation , design reviews, design transfer, and all other aspects of a design ... * Strong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab or other statistical softwares.… more
- Teleflex (Morrisville, NC)
- …adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a best-in-class, diverse, Applications ... meeting project objectives * Strong communication skills * Experience in an FDA regulated environment preferred * Project Management and/or Lean Six Sigma… more
- Teleflex (Morrisville, NC)
- …to support activities in product and process design, such as design verification, validation , reviews, transfer, and all other aspects of a design history file. * ... * Basic understanding of industry regulations such as ISO 13485, ISO 14971, and FDA 21CFR820. * Proficient in MS Office and Minitab or other statistical software. *… more
- Lilly (Durham, NC)
- …shifts, weekends for facility startup. + Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg ... cGMP's, FDA 21 CFR Part 11) and other applicable regulations (eg privacy, OSHA, etc.). + Demonstrated ability to lead and influence cross-functional teams 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 ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more