- GRAIL (Raleigh, NC)
- … quality to help keep these systems operational while adhering to GxP/ GLP/ GMP regulations and quality standards when applicable. Strict adherence to Standard ... Operating Procedures, Work Instructions, and Quality Standards in a FDA -regulated facility are mandatory. In addition, this individual will also be involved in… more
- Fujifilm (Holly Springs, NC)
- …reports * Liaises with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of ... * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …following OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + ... Directions while maintaining compliance with all job-related SOPs + Quality + Ensure that all batch paperwork is completed...deviation analysis, CAPA actions and other process equipment related quality concerns + Maintain all work areas in a… more
- Actalent (Durham, NC)
- …role requires adherence to standard operating procedures and a commitment to quality and safety standards. Responsibilities + Set up, operate, monitor, and control ... and author SOPs and other required documents. + Identify, report, and resolve quality issues. + Execute or assist in equipment maintenance, including restoration of… more
- Actalent (Durham, NC)
- …equipment to achieve production goals while adhering to safety and quality standards. Responsibilities + Set up, operate, monitor, and control equipment, ... SOPs and other necessary documents. + Identify, report, and resolve quality issues. + Execute and/or assist during equipment maintenance, including restoration… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …following OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + ... Directions while maintaining compliance with all job-related SOPs + Quality + Ensure that all batch paperwork is completed...deviation analysis, CAPA actions and other process equipment related quality concerns + Maintain all work areas in a… more
- Stantec (Raleigh, NC)
- …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …following OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + ... per approved Manufacturing Directions while maintaining compliance with all job-related SOPs Quality + Ensure that all batch paperwork is completed in an accurate,… more
- BioLife Plasma Services (Raleigh, NC)
- …tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... your skills by contributing to financial, marketing, administrative, regulatory, quality , people, and facilities management. + **Contribute to Creating Life-Changing… more
- ThermoFisher Scientific (Greenville, NC)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **GROUP/DIVISION SUMMARY** The ... of leadership experience required. + Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. +...sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. +… more