- ThermoFisher Scientific (Greenville, NC)
- …Knowledge** : Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP ) is highly desirable. + **Certifications** : Relevant ... (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **Job Summary:** We are… more
- Actalent (Hickory, NC)
- …Skills + Quality assurance + GMP + Data + Compliance + CAPA + FDA + Batch record + Investigation + Root cause analysis + Audit Additional Skills & Qualifications ... local Internal Audit program and associated follow-ups. Coordinates the monthly GMP inspection program and associated follow-ups. Supports the facilitation of… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …documents, and improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP , ISO, HSE (OSHA), Department Procedures, and ... will also be required to work autonomously in a GMP environment in addition to being an active contributor...manufacturing line is operating at optimum level for a GMP environment in a safe manner while meeting production… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …ability to work as part of a team with minimal supervision. + Knowledge of FDA and/or GMP regulations preferred. + Prior ERP experience preferred. + Prior ... controlled documents in accordance with company policies and regulatory agency (eg, FDA and ISO) requirements. + Provide assistance with the review and revision… more
- Reckitt (Wilson, NC)
- …improvements with engineering, maintenance, and production teams. + Maintain regulatory alignment ( GMP , FDA , ISO, EHS) and current schematics. + Execute ... regulatory compliance, and electrical codes..Strong knowledge of regulatory standards (eg, GMP , FDA , ISO 9001/13485). + PE (Professional Engineer) License… more
- Lilly (Concord, NC)
- …or technical certification in a related field is a plus + Knowledge of FDA and GMP regulations + Experience operating high-speed, automated production equipment, ... with equipment setup and changeovers to support production needs + Adhere to all GMP and quality standards + Must have the ability to quickly and accurately diagnose… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …documents, and improves procedures and Preventative Maintenance Activities. a. Adherence to FDA Regulations, GMP , ISO, HSE (OSHA), Department Procedures, and ... skills (written & verbal). 5. Strong attention to detail with GMP experience including knowledge of change control, validation and commissioning process… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …Adherence:** + Ensure all SAP PP/QM solutions comply with relevant regulatory requirements, including GMP , FDA 21 CFR Part 11, and other applicable standards. + ... SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release...operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient,… more
- Reckitt (Wilson, NC)
- …and integrate cutting-edge technologies for performance optimization. + Drive regulatory alignment ( GMP , FDA , ISO, EHS) across automation activities and support ... design using AutoCAD Electrical or EPLAN. + Experienced in regulatory compliance: GMP , FDA , ISO 9001/13485, EHS, electrical codes, and safety standards. + Strong… more
- Fujifilm (Holly Springs, NC)
- …electrical, plumbing, chemical treatment, and control systems + Familiarity with GMP , FDA , and other regulatory requirements + Effective communication, ... ensuring compliance with safety, regulatory, and Good Manufacturing Practices ( GMP ) standards. Additionally, this role also provides training, technical support,… more