- Fujifilm (Holly Springs, NC)
- …processes 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… more
- Ingersoll Rand (Lillington, NC)
- …regulations, adhere to KSE SCIENTIFIC policies, and adhere to KSE SCIENTIFIC SOP and Batch Record directions. + Complete all necessary documentation in a manner ... ERP experience, + Minimum of High School Diplomacy or equivalent GED + Clean driving record + Ability to bend, stoop or lift objects weighing up to 75 pounds; stand… more
- Fujifilm (Holly Springs, NC)
- …or projects * Proven ability to lead teams * Experience with electronic batch records , root cause analysis, technical writing, and initiation of investigations ... **Preferred Requirements** * Experience working in facility start-up environment * Experience working in a pharmaceutical manufacturing environment * 1-3 years of leadership experience * Lean Six Sigma or similar certification **WORKING CONDITIONS & PHYSICAL… more
- Lilly (Greenville, NC)
- …support. + Maintain awareness of issues and ensure resolution. + Assist with batch records and revisions. + **Process Improvement:** + Evaluate process ... capability and yield variables. + Monitor processes using statistical tools to reduce variability and improve consistency. **Relationship with JPT:** + Ensure technical agenda is agreed upon and executed timely. + Identify and conduct training for the External… more
- ThermoFisher Scientific (High Point, NC)
- …weights, raw material lot numbers, part numbers, and expiration dates against batch production records (BPR). + Follow BPR procedures meticulously without ... deviation. + Align with workplace policies, procedures, and guidelines including SOPs, cGMPs, MSDS, and other departmental documents. + Ensure all documentation is accurately written, initialed, and dated according to SOPs. + Perform detailed cleaning of the… more
- Amgen (Holly Springs, NC)
- …in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) + Identify and escalate issues and ... concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions + Perform documentation for assigned functions (ie, equipment logs, EBRs) + Collaborate as part of a cross-functional team (ie, QA/QC, F&E… more
- Pfizer (Sanford, NC)
- …execution of approved protocols, incorporating defined parameters into operating procedures and batch records . + Assist with the development of validation ... protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions. + Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety… 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… more
- Pfizer (Sanford, NC)
- …skids 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**… more
- Pfizer (Sanford, NC)
- …**Participate in the authoring role** for controlled documentation; SOPs, Manufacturing Batch /Formulation Records , Forms, etc. + **Collaborates with** the ... Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations. + Responsible for remaining current on assigned training. + **Leads** Lean Manufacturing, Sustainability and Operational Excellence initiatives;… more