- 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …+ Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities ... associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract… more
- US Tech Solutions (Thousand Oaks, CA)
- …for training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review , and acting as a QA liaison ... and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval,… more
- PCI Pharma Services (San Diego, CA)
- …required. + Oversees CoA generation of batch records . + Supports batch record review . + Ensures training of all direct and indirect reports of ... microbiological test assays and environmental monitoring. + Regular and reliable attendance on a full-time basis for self and team [or in accordance with posted schedule]. **Requirements:** + Bachelor's Degree in Life Sciences field or equivalent experience… more
- Actalent (Ontario, CA)
- …testing, including raw material and finished product testing. + Manage document control, batch record review , and quality management systems. Essential ... and corrective actions to maintain the highest quality standards. Responsibilities + Review analytical testing results and ensure proper documentation. + Train and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products ... and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides… more
- VTI Life Sciences (Los Angeles, CA)
- …o Validate the manufacturing process and critical process parameters. o Generate and review batch records and documentation. Process Validation o Conduct ... process validation studies to ensure consistent product quality. o Perform risk assessments and implement process controls. o Develop and validate analytical methods for product testing. Cleaning Validation o Validate the cleaning procedures for the equipment… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …degree. + Requires an in-depth understanding of pharmaceutical manufacturing, and quality review relating to production batch records . + Comprehensive ... 110 countries and regions. **POSITION SUMMARY** Responsible for the review of manufacturing batch documentation and the...SUMMARY** Responsible for the review of manufacturing batch documentation and the preparation of product releases and… more
- Astrix Technology (Gardena, CA)
- …and entering data into internal systems. No lab work. **Key Responsibilities:** + Review and process batch records (non-regulated to pharmaceutical-grade ... data into internal databases + Ensure compliance with cGDP standards + Generate/ review documents (eg, Certificates of Analysis) + Coordinate with labs and… more
- WSP USA (Costa Mesa, CA)
- …and operations to assist customers and resolve problems + Open, sort, count, and batch incoming payment processing mail + Review and respond to incoming mail ... unapplied or unidentified payments + Process returned mail + Maintain customer records by updating account information + Process inbound mail which includes payments… more