- 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
- Fujifilm (Santa Ana, CA)
- …and follow up actions + Assist with change notification and supplier management + Assist with batch record review or other duties as needed + Assist with ... coordination of quality activities for related FISI production sites **Required Skills/Education:** + **BS/BA in Biology, Microbiology, or Chemistry** + **3-5 years of QA experience in medical device or biopharmaceutical environment** + Must be familiar with… more
- Fujifilm (Thousand Oaks, CA)
- …personnel + Documentation and Compliance: Write manufacturing documents for cellular therapies, review batch records , and initiate deviations as necessary ... + Regulatory Support: Collaborate with the quality group and contract manufacturing organization to support regulatory filings for clinical programs + Process Improvements: Identify and implement continuous improvements in manufacturing processes and ensure… 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
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …revise current department policies and procedures including departmental SOPs and Batch Records for all QC functions. + Review and approve all required ... documentation, including QC Batch Records , change notifications and SOPs. + Perform, maintain and document routine training program for departmental employees.… more
- Catalent Pharma Solutions (San Diego, CA)
- …teams to communicate project requirements and gather appropriate paperwork for batch records . Provide batch record training to production team on complex ... responsibilities of this position include activities related to supply chain, procurement, batch record and label creation, and other project management and… more
- Guidehouse (San Marcos, CA)
- …compensation folders for remittances that need prepping for imaging. + Post and review special projects. + Records maintenance. + Assist opening mail when ... Payment prep and posting. + Sign out for payment batch on batch log with time received....Supervisor before putting payments on an unapplied invoice. + Review of statements. + Review billing statements… more