- 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
- 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
- ThermoFisher Scientific (High Point, NC)
- …performance records and data + Builds and revises systems, batch paperwork, and procedures by analyzing operating practices, record -keeping systems, ... or helping find cures for cancer. **Excellent Benefits Package** Review our company's Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards) Medical, Dental, &… more
- Pfizer (Sanford, NC)
- …execution of approved protocols, incorporating defined parameters into operating procedures and batch records . + Assist with the development of validation ... work. **What You Will Achieve** In this role, you will: + Evaluate, review , and approve validation master plans, protocols, and reports, ensuring compliance with… more
- Merck (Wilson, NC)
- …Technical writing experience with investigations, change requests, standard operating procedures, batch records , protocols * Demonstrated data analysis skills ... maintenance teams to drive efficient utilization of manufacturing assets. * Review volumes, determining opportunities and risks and defining performance targets. *… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …samples for investigation purposes, where applicable. + Coordinates the reviews of relevant records , (eg batch records , quality control data, quality ... information from departments for performing QMR and annual product review + Establish, revise, review and continuously...and annual product review + Establish, revise, review and continuously improve procedures for all Quality Systems.… 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
- 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
- Lilly (Durham, NC)
- …SAP master data management, change management, deviation management, procedure management, review of specifications, review and approval of cGMP documents, ... and manage quality master data in SAP including q-info records and inspection plans for materials. + Protect the...Support onboarding of new materials in TrackWise. + Effectively review /approve GMP documents to ensure quality attributes are met… more