- ThermoFisher Scientific (San Francisco, CA)
- …+ 2+ years of dynamic proven experience in applicable field with GXP experience preferred + Ability to establish and champion positive customer relationships ... **Knowledge, Skills, Abilities** + Utilization of Good Documentation Practices in all record keeping + Strong interpersonal skills and proactive approach in all duties + Demonstrate expertise in the ability to identify inefficiencies in any process and make… more
- Cordis (Irvine, CA)
- …business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation activities **Qualifications** ... + 7+ years as a Business Analyst, Functional Consultant, or Systems Analyst in a manufacturing setting. + Bachelor's degree in industrial engineering, information systems, or similar discipline; or equivalent experience. + Hands-on expertise with JD Edwards… more
- Gilead Sciences, Inc. (Foster City, CA)
- …managing local and global change controls and associated activities related to GxP operations. + Navigate through complex change review discussions, facilitating to ... a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly. + Supports management and monitoring of change records for adherence to organizational or departmental metric… more
- Gilead Sciences, Inc. (Foster City, CA)
- …distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations . Possesses strong collaboration, influencing and negotiation skills ... to work effectively with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. . Leads through ambiguity, can assess options quickly and efficiently implement the best option in alignment with… more
- BeOne Medicines (San Mateo, CA)
- …Manage the complete lifecycle of GCO role-based curricula in accordance with GxP requirements. + Ensure curricula accurately reflect current SOPs, work instructions, ... regulatory guidance, and process changes. + Monitor training completion and escalate noncompliance to functional leaders and QA as needed. + Support audit and inspection readiness by ensuring all training documentation and audit trails are accurate and… more
- Cognizant (Sacramento, CA)
- …business systems analyst with a deep understanding of business processes under GxP , ISO, and regulatory compliance Knowledge of Mfg. Process Controls and Reporting ... program Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry Experienced in Camstar (V8.x)… more
- BeOne Medicines (San Mateo, CA)
- …Improvement** + Ensure KPIs and analytics processes comply with applicable GxP and regulatory guidelines. + Support audit readiness and documentation standards ... for performance tracking systems. + Lead improvement initiatives across clinical functions informed by metric analysis. **Supervisory Responsibilities:** Lead and manage a global team of visualization experts, analytics leads, and domain specialists. Provide… more
- Kelly Services (Sacramento, CA)
- …regulations + Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards. + Experience in quality administered systems. + ... Experience with regulatory compliance and documentation. + Ability to mentor and review the work of other colleagues. + Knowledge of electronic systems such as Compliance wire., Veeva, Track wise, SAP, LIMS, Maximo, and Master Control. + Collaboration skills… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …(AWS, S3 buckets), and data science infrastructure (Databricks, H2O.ai) + Knowledge of GxP and GMP, lab instrument automation, and IT infrastructure development is a ... plus + Strong communication, problem-solving, and troubleshooting skills + Ability to thrive in a fast-paced, dynamic environment with minimal direction The salary range for this position is: $115,260.00 - $149,160.00. Kite considers a variety of factors when… more
- VTI Life Sciences (San Diego, CA)
- …for CQV (ISPE Baseline Guide, ASTM E2500) and temperature mapping in a GxP (good practices) regulated environment. As you progress, you will have the opportunity ... to support future projects of increasing complexity and specialization as you navigate your career in this always-in-demand field. Qualifications: + Bachelor's degree or higher in Engineering, Life Sciences, or related discipline (Mechanical Eng., Chemical… more