- ThermoFisher Scientific (Greenville, NC)
- …to area SOPs and current cGMP. + Verify and document production activities in batch records , logbooks and controlled forms. + Complete tasks vital to manufacture ... drug products in an aseptic filling area, including: + Cleaning cGMP Areas + Parts Preparation + Filter Integrity Testing + Operating Parts Washers and Autoclaves + Performing Tray Loading + Operating the Filling Isolator + General Material Handling +… more
- Catalent Pharma Solutions (Greenville, NC)
- …scale-up, bio-batches, full commercial scale batches, and CTM batches. + Ensure all batch records and logbook entries are accurately documented and compliant ... with SOPs and FDA cGMP guidelines. + Assist with setup, manufacturing, and changeovers with adherence to SOPs and safety requirements. + All other duties as assigned. **The Candidate** + High school diploma or equivalentwith at least 1 year of manufacturing or… more
- ThermoFisher Scientific (Greenville, NC)
- …with area SOPs and current cGMP. + Verify and document production activities in batch records , logbooks and controlled forms. + Complete tasks vital to ... manufacture drug products in an aseptic filling area, including: + Cleaning cGMP Areas + Parts Preparation + Filter Integrity Testing + Operating Parts Washers and Autoclaves + Performing Tray Loading + Operating the Filling Isolator + General Material… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …for multiple categories of defects. + Document job tasks as required on the Batch Production Record (BPR), Standard Operating Procedure (SOP) document or other ... acceptable form(s). + Perform housekeeping tasks and maintain department housekeeping at an optimal level. + Adhere to all company safety and cGMP policies and practices. + Meet and maintain visual inspection recertification requirements through knowledge of… more
- Amgen (Holly Springs, NC)
- …Analytics/Notifications, PI Vision, PI Web API, and Interfaces (OPC, RDBMS, PItoPI, Batch , BACnet) plus RtReports. + Pharma / GxP regulated‑environment experience. + ... OPC UA, BACnet, Kepware, Matrikon). + Customer‑centric mentality with a track record of building trusted customer relationships. + Self‑motivated and quick to learn… more
- ThermoFisher Scientific (Greenville, NC)
- …Life:** + 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,… more
- ThermoFisher Scientific (Greenville, NC)
- …review, and approve production, validation, and audit reports, as well as master batch record documents, procedures, and rationales. + Evaluate new regulations ... and changes to existing ones, performing gap analysis to determine and address deficiencies. + Establish and implement systems to achieve process improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA, MCA, and other agencies.… more
- ITW (Raleigh, NC)
- …get products identified with manufacturing codes - such as lot codes, date codes, batch codes, barcodes - and out the door quickly and efficiently. Diagraph culture ... origin, age, disability, sexual orientation, marital status, veteran status, arrest record , citizenship or other categories protected by federal, state or local… more
- Bandwidth (Raleigh, NC)
- …build, and optimize ETL/ELT data pipelines to support various business units, balancing batch and streaming solutions. Leverage tools like AWS DMS, RDS, S3, and ... software architecture in the data engineering domain. + Demonstrated track record of operating in highly collaborative, flexible, and productive cross-organization… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …+ Production + Operate cleaning equipment, utilize SOP and documentation to record data manually or through identified software applications. + Operate high speed ... while maintaining compliance with all job-related SOPs Quality + Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner + Perform… more