- ThermoFisher Scientific (Greenville, NC)
- …QA representative in root cause analysis to support deviation investigations. + Perform batch record review . **Qualifications:** + Associate's degree in ... with respect to manufacturing, filling, packaging and inspection, and associated non batch specific activities in the Sterile facility for both commercial and… more
- ThermoFisher Scientific (Greenville, NC)
- … Batch Release oversees QA activities and programs such as auditing, record review , final product functions, document management, complaints, oversight of ... goals. + Supervision: Supervise staff performing quality and manufacturing audits, record review , final product release functions, complaints, APR, validation,… more
- ThermoFisher Scientific (Greenville, NC)
- …scale-up and commercialization, supporting the development of mitigation strategies. + Draft and review batch records , protocols, and reports to support ... manufacturing processes for oral solid dosage (OSD) products in both traditional batch and continuous manufacturing environments. You will contribute to scaling up… more
- Mentor Technical Group (NC)
- …and South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review experience. + Available for non-standard ... shifts which include nights and weekends. + Basic knowledge of the process, PASx/MES application, MAXIMO, SAP, and LIMS. Education & Qualifications + Bachelor's degree and 5 years of directly related experience or Master's degree and 3 years of directly… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change ... of upstream process changes and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …+ Provide expert technical oversight of downstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change ... of downstream process changes and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …required by production leadership. + Review and correction of area specific executed batch records and log books to meet timely closure of the documents. + ... equipment (as needed) by following standard operating procedures and batch records in accordance with FDA Current...Review , correction and close out of area specific batch records . - Maintain documentation and functional… more
- Actalent (Durham, NC)
- …and skill level. + Record and review production data in Batch Production Records (BPR) and associated forms. + Follow all safety and environmental ... management, and returns. + Participate actively in and support event response. + Review and author SOPs and other necessary documents. + Identify, report, and… more
- Fujifilm (Holly Springs, NC)
- …procedures * Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review , including exception-based oversight using Quality ... Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures * Ensures department objectives are met within… more
- Fujifilm (Holly Springs, NC)
- …procedures * Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review , including exception-based oversight using Quality ... Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures * Ensures department objectives are met within… more