- 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
- 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …+ Provide expert technical oversight of upstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change ... of upstream process changes and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …+ Provide expert technical oversight of downstream manufacturing operations at CDMOs, including review of batch records , deviation investigations, and change ... of downstream process changes and improvements post-approval. + Author and/or review technical reports, protocols, risk assessments, and relevant sections of… more
- CTG (Woodland, CA)
- …to ensure procedural accuracy and compliance with cGMP and ISO 13485 * Conduct initial review of completed batch records for Good Documentation Practices * ... documents and change control routings * Issue labels and batch record documentation for all products *...documentation for all products * Issue and maintain training records for all employees * Coordinate the review… more
- ManpowerGroup (Pomona, CA)
- …investigations and stability verification. + Generate product testing results reports and review production batch records for accuracy and completeness. ... of production operations and participate in the internal audit program. + Write, review , and approve Standard Operating Procedures (SOPs) as necessary. + Assist in… 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
- Vera Therapeutics (Brisbane, CA)
- …Oversight of CPV implementation, data trending, and assessment of process capabilities. * Prepare, review , or edit cGMP batch records , CMC regulatory and ... the ideal candidate must be an outstanding leader with a proven track record of strategic planning and execution in drug product manufacturing having advanced… more
- ThermoFisher Scientific (Fremont, CA)
- …for non-conformances, CAPAs, and variances. + Weigh, transfer, and mix required chemicals. + Review and approve batch records and manage materials in ERP ... as needed. + Train other chemists on equipment and procedures. + Write, review , or modify SOPs, work instructions, and reports. + Maintain, troubleshoot, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or review GMP or non-GMP technical documentation (development reports, process description, batch records , etc) Author and review CMC related regulatory ... sections Demonstrates technical proficiency and scientific creativity in improving platform technology Demonstrates ability in communicating ideas, project strategies and results to team members across functional roles/departments Mentor junior team members on… more