- ITG Brands (NC)
- …regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations & ... process and how to generate manufacturing control plans. + Generation of validation master plans and manufacturing control plans. + Large manufacturing facilities… more
- Fujifilm (Holly Springs, NC)
- …preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of ... ID systems (MALDI, MicroSeq) * Intermediate LIMS training * Knowledge or training of FDA regulations (cGMP, cGLP, cGDP) * Trackwise System training * Lean / 6S… more
- 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)
- …work with other maintenance and technical trades, contractors, engineers, metrology, validation , and quality to help keep these systems operational while adhering ... to Standard Operating Procedures, Work Instructions, and Quality Standards in a FDA -regulated facility are mandatory. In addition, this individual will also be… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …proceed with proper decision making + Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability… more
- Fujifilm (Holly Springs, NC)
- …role, required + 3+ years of experience in GMP operations in an FDA regulated facility **Preferred Requirements:** + Experience and working knowledge of ASTM E2500, ... + Training and/or familiarity with Quality Risk Management principles + Validation , cGMP manufacturing operations and/or Quality oversight **Physical and Work… more
- Catalent Pharma Solutions (Greenville, NC)
- …organizations (CMOs and CPOs). **The Role** + Act as Commercial QA SME during FDA , non-domestic and client audits and lead preparation of responses to all audit ... cross-functional teams, such as Technical Services, facilities, Engineering and Validation . + Demonstratable leadership experience at Catalent (including but not… more
- Eliassen Group (Raleigh, NC)
- …main focal point for the component system, including data collection, data validation , meeting coordination, rollout execution, and progress updates + Perform risk ... actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to… 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 ... environment. + Proficiency in machining, welding, and fabricating. + Knowledge of change control, validation , and commissioning processes. #biojobs #LI-US 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 ... Integrity program activities. + Works with QC laboratories, manufacturing, QA, IT, and validation teams. + Ensures tasks and documentation are aligned with GMP, GDP,… more