- Genentech (South San Francisco, CA)
- …San Francisco campus. The specialist will be a member of the SMAC Equipment and GMP Operations Group. This role will be responsible for: + Qualification of GMP ... Control records as Change Owner as needed; and supporting GMP audits as equipment validation and compliance SME. +...will be used to support the daily operations and GMP compliance of our state-of-the-art analytical labs and instruments.… more
- Genentech (San Diego, CA)
- …Put away received materials in appropriate locations in the warehouse. + Perform GMP receiving according to procedure and Good Documentation Practice (GDP). + Issue ... materials to manufacturing in accordance with GMP procedures. + Support manufacturing for after-hours product storage....of received materials in accordance with hazard, safety, and GMP guidelines. + Perform cycle counts of materials in… more
- Insight Global (Berkeley, CA)
- …with Biological Development and Tech Transfer teams. * Maintain GMP compliance, perform environmental monitoring, and ensure accurate documentation (Batch ... and Requirements * Manufacturing Experience: Hands-on experience in pharmaceutical or GMP -compliant manufacturing, ideally with exposure to cell therapy and upstream… more
- Parexel (Sacramento, CA)
- …**Required Skills and Experience** + Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring + Proven technical ... submit equipment for calibrations (offsite or onsite) + Complete calibration/PM paperwork GMP ACTIVITIES: + Prepare GMP documentation as requested by management… more
- Amgen (Thousand Oaks, CA)
- …process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen's ... owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards. + Maintain documentation to accurately reflect operational… more
- Gilead Sciences, Inc. (Foster City, CA)
- …digital ambitions. The scope of this role will include the existing API and OSD GMP manufacturing facilities as well as take a leading role in designing a new state ... AI-driven data flows. + Standardize architecture for LIMS, MES, PCS, Historian, e-Validation, GMP and non- GMP reporting, and AI-enabled digital systems. + Ensure… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …controlled substances across the product lifecycle meet Good Manufacturing Practices ( GMP ) and comply with global regulatory requirements, including DEA regulations. ... applicable) regulatory requirements. **Key Responsibilities** + Product Oversight: Provide GMP oversight and guidance during the drug development process including… more
- Gilead Sciences, Inc. (Foster City, CA)
- …oversight of manufacturing/testing, and independence from production per our GMP Quality Manuals (Gilead/Kite). + Hands-on leadership ensuring **QA ... responsibilities** are executed: complaints handling, investigations, escalation of serious GMP issues, internal audits/self-inspection, and training effectiveness. + Demonstrated… more
- PCI Pharma Services (San Diego, CA)
- …and Roselle The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing ... associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves,… more
- Amgen (Thousand Oaks, CA)
- …process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen's ... owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards. + Maintain documentation to accurately reflect operational… more