- Stantec (Raleigh, NC)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The commissioning and… more
- ITG Brands (NC)
- …regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations & ... analysis (eg, capacity, OEE calculations). + Productdesign/implementation. + Regulatory submissions. + GMP + Deep understanding of the pFMEA process and how to… more
- 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 the… more
- Fujifilm (Holly Springs, NC)
- …of applicable experience * 3+ years of experience working in a GMP regulated environment * Experience in Validation, cGMP manufacturing operations and/or Quality ... oversight, in an FDA regulated facility. **Preferred Requirements:** * Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl and/or… more
- ThermoFisher Scientific (Greenville, NC)
- …eg, pharmaceuticals, manufacturing, etc.]. + Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. + Strong analytical and problem-solving ... with electronic documentation systems. + Familiarity with Good Manufacturing Practices ( GMP ) and Good Laboratory Practices (GLP). **Working Conditions:** + This job… more
- ThermoFisher Scientific (Greenville, NC)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **GROUP/DIVISION SUMMARY** The ... build/refurbishment of sterile lines) would be beneficial. + Familiarity with US FDA , EU Annex-1 and other regulations and guidance. + Strong investigative skills,… more
- Fujifilm (Holly Springs, NC)
- …* Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC ... Contract Laboratory Organization (CLO) * 4-6 years experience in a GMP environment **Preferred Requirements:** * MS in Chemistry, Biochemistry, Biological Sciences,… more
- Fujifilm (Holly Springs, NC)
- …or Engineering and without any experience * 3+ years of experience in GMP Quality Assurance and/or similar role * Experience in Validation, cGMP manufacturing ... operations and/or Quality oversight, in an FDA regulated facility. * High level of familiarity/understanding of validation of production equipment, hygienic… more
- Kelly Services (Clayton, NC)
- …+ Documentation and data integrity + Laboratory operations + Regulatory compliance ( GMP /GxP) + Budget planning and oversight + Employee relations and staffing + ... of relevant experience **Preferred Experience:** + Experience interfacing with the FDA , including license submissions, inspections, and audit follow-up + Background… more
- Mentor Technical Group (NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... policy and procedures, and regulations. + Lab Equipment/systems may include GMP equipment's such as: (KFT (Coulometric), FT-NIR, LIF, NIR, Homogenizer,… more