- Boehringer Ingelheim (Fremont, CA)
- …The Specialist trains junior modelers to learn how to generate batch records , generates and refines batch record creation training materials, and ... records in BioMES. Leads team to create new batch record types and systematically evaluate information...business process owner for BioMES business processes such as batch record templates, review processes,… more
- Catalent Pharma Solutions (San Diego, CA)
- …cGMP (Good Manufacturing Practices) regulations + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents + Liaison ... between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status + Tracks status of Executed … more
- LGC Group (Petaluma, CA)
- …completeness and compliance with cGMPs as per regulatory requirements and internal procedures. Review batch records , summary reports and other release ... of incoming Raw Material records for completeness and disposition + Batch Review : Perform technical review of the manufacturing batch records for… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …quality standards across global markets. You will oversee critical quality systems including batch record review , product release, change control, deviation ... applicable geographies + Ensure adherence to facility quality systems such as batch record review , product release, change control, deviation management, and… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …quality, increase efficiency, produce cost savings, and provide new product support. + Perform Batch Record Review to ensure compliance with procedures. + ... daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review ...for improvements to reduce recurring non-conformances and improve. + Review and release batch records … more
- Actalent (Carpinteria, CA)
- …change control, Agile, word, outlook, Qc, Filing, Clerical, Administration, Biology, Chemistry, Batch record review , Sop, Document management Top Skills ... Skills Quality, Administrative, calibration, Ms Office Suite, SAP, Excel, scanning, batch record , data entry, documentation, controlled documents, detail… more
- Actalent (Carpinteria, CA)
- …change control, Agile, word, outlook, Qc, Filing, Clerical, Administration, Biology, Chemistry, Batch record review , Sop, Document management Top Skills ... Skills Quality, Administrative, cGMP, Ms Office Suite, SAP, Excel, scanning, batch record , data entry, documentation, controlled documents, detail oriented,… more
- Kelly Services (Sacramento, CA)
- …expectations. + Review and approve sampling protocols, risk assessments, and master batch records . + Author, review and approve SOPs as appropriate ... team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close… more
- Kelly Services (Lodi, CA)
- … records and documents, for completeness and compliance with QSR and ISO requirements. + Review batch record to support release of raw materials, work in ... The Quality Assurance Specialist I is responsible for reviewing records to comply with QSR and ISO requirements. They...signing in relevant sections of documents. + Reviewing the batch records online, if necessary. + … more
- Amgen (Thousand Oaks, CA)
- …presence on the manufacturing floor, inc. Inspection support, ASP and QA assessments + Electronic batch record review + SOP revision approval + Maximo System ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area… more