- Fujifilm (Holly Springs, NC)
- …in an FDA regulated facility **Preferred Requirements** * 2+ years of experience in GMP Quality Assurance and/or similar role * Experience and working knowledge ... Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of… more
- Fujifilm (Holly Springs, NC)
- …+ Bachelor's degree in Life Sciences or Engineering and 8+ years ofexperience in GMP quality assurance and/or similar role OR + Master's degree in Life ... Sciences or Engineering and 6+ years ofexperience in GMP quality assurance and/or similar role. + 2+ years of direct supervisory experience + Excellent oral and… more
- Amgen (Holly Springs, NC)
- …experience interacting with regulatory agencies and inspectors. + Familiarity with GMP quality systems/processes such as change control, non-conformances, ... restarts to avoid impact to plant operations. + Ensure plant readiness and Quality and Regulatory compliance for internal and external audits related to the… more
- Fujifilm (Holly Springs, NC)
- …(SOPs) and protocols to ensure compliance with safety and Good Manufacturing Practices ( GMP ) quality standards + Adheres to all safety requirements and follows ... environment + Effective communication, both written and oral + Knowledge of GMP requirements and programmable logic controllers (PLC) and other process control… more
- Fujifilm (Holly Springs, NC)
- …+ Follows SOPs to ensure compliance with safety and Good Manufacturing Practices ( GMP ) quality standards + Adheres to all safety requirements and follows ... Skills** + Knowledge of mechanical, electrical, and control systems + Knowledge of GMP requirements + Effective communication, both written and oral + Ability to… more
- Astellas Pharma (Sanford, NC)
- …of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, ... Quality Culture' by coaching in the application of GMP principles including the underlying rationale of those principles....+ Author, review and approved controlled documents for the Quality organization and other GMP functional areas… more
- Lilly (Durham, NC)
- …Quality culture. + Ensures regular presence in warehouse and logistics areas to monitor GMP programs and quality systems. + Reviews and approves GMP ... through philanthropy and volunteerism. **Position Brand Description:** The Technician Warehouse Quality Assurance works as a member of the Warehouse QA team.… more
- Fujifilm (Holly Springs, NC)
- …Sciences or Engineering and without any experience * 3+ years of experience in GMP Quality Assurance and/or similar role * Experience in Validation, cGMP ... DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance...the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams.… more
- Lilly (Concord, NC)
- …batch disposition processes. + Provide guidance to operational teams to ensure robust quality systems and ongoing GMP compliance. + Participate in self-led ... Serving as a business subject matter expert (SME), this role will represent Quality Assurance (QA) throughout the project. The primary responsibility of this role is… more
- Lilly (Concord, NC)
- …Assist with equipment setup and changeovers to support production needs + Adhere to all GMP and quality standards + Must have the ability to quickly and ... a dynamic manufacturing environment. **Key Responsibilities** + Promote a safety-first, quality -always culture in all tasks and interactions + Improve equipment… more