- Actalent (Durham, NC)
- …appropriate experience and skill level. + Record and review production data in Batch Production Records (BPR) and associated forms. + Follow all safety and ... environmental requirements in the performance of duties. + Complete other assigned accountabilities. Essential Skills + Experience in production, with preference for bio works. + Experience in an FDA-regulated environment. + High School Diploma with 1-3 years… more
- ThermoFisher Scientific (Greenville, NC)
- …to process scale-up and commercialization, developing mitigation strategies. + Prepare batch records, protocols, and reports for development, validation, and routine ... production. + Act as technical steward for assigned products, supporting routine manufacturing. + Investigate new scientific methodologies for controlling raw materials, intermediates, and final products. + Implement strategies and technical solutions to meet… more
- Catalent Pharma Solutions (Morrisville, NC)
- …+ Generate related documents, including Standard Operating Procedures (SOPs), Batch Documentation, Validation Plans, Protocols, and Evaluations + Provide technical ... and operational support to meet internal and external customer requirements + Support technology transfers from client or product development into the facility and, when applicable, to commercial manufacturing + Develop and progress continuous improvement… more
- Pfizer (Sanford, NC)
- …and/or UF/DF skids with varying levels of automation. + Follow SOPs and batch records for unit operations + Supports operation of manufacturing equipment and issue ... resolution associated with process equipment commissioning, qualification and validation. + **Drives** troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor. + **Drives** for Right… more
- Merck (Wilson, NC)
- …writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc. + Demonstrated ability to work independently ... as team member + Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment + Willing to work irregular hours (as needed) to support a multi-shift operation's shop-floor… more
- Herbalife (Winston Salem, NC)
- …physical testing. * Document all experiments and result in development batch records/protocols and/or laboratory notebooks and electronic files. * Sets-up, maintain, ... and clean laboratories equipment and work area. * Maintain raw material inventory. * Follow all safety procedures and practices. Maintain a safe work environment. * Implement detailed observations, analyze data, and interpret results. * Write formal scientific… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Prepare, review, and approve production, validation, audit reports, master batch record documents, procedures, and rationales. + Establish systems to ensure ... compliance with new and changing regulations and conduct quality systems training across the company. + Identifying areas of non-compliance and implementing solutions to resolve major quality and efficiency issues will be key responsibilities. + Manage, lead,… more
- The Hartford (Charlotte, NC)
- …to establish portfolio flow to visualize and limit Work in Process WIP, reduce batch sizes of work, and control the length of longer-term development queues. * ... Assist with establishing and maintaining an overall CIO portfolio view. Qualifications: * Strong financial acumen and knowledge of IT financial management practices. * 3 years of portfolio management experience or equivalent experience (Scrum Master, RTE,… more
- Fujifilm (Research Triangle Park, NC)
- …microbiological testing of clean utility, environmental monitoring, and manufacturing batch samples. This role performs routine laboratory testing and support ... activities and actively participates in continuous improvement initiatives. **Company Overview** At FUJIFILM Biotechnologies, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's most… more
- Fujifilm (Holly Springs, NC)
- …and 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 desired… more