- Gilead Sciences, Inc. (El Segundo, CA)
- …is also beneficial. Previous experience working in a Good Manufacturing Practice ( GMP ) environment is a must. This role will be responsible for working ... revise, and approve LIMS system SOPs and reports per GMP , FDA, EU, Global, and ICH guidelines + Triage...deployment + Ensure LIMS processes meet data integrity and GMP standards; promote global process adoption **Basic Qualifications** +… more
- Genentech (Oceanside, CA)
- …the support of Product Transfers and Make/Assess/Release in a 24x7 Good Manufacturing Practice ( GMP ) environment. As part of the Site Team and larger Global IT OT ... alerts and logs. + Support virtualization (VMware) and system redundancy for critical GMP applications. **Compliance & Validation** + Ensure systems meet GxP and FDA… more
- Mentor Technical Group (Millbrae, CA)
- …responsible for maintaining, repairing, and troubleshooting equipment and systems in GMP -regulated environments. The ideal candidate will be skilled in multiple ... corrective maintenance on mechanical, electrical, and HVAC systems within regulated ( GMP ) areas. + Troubleshoot systems using electrical and mechanical diagnostic… more
- Catalent Pharma Solutions (San Diego, CA)
- …collaborate with other departments to troubleshoot technical issues. Familiarity with current GMP regulations is required + Individuals will stay abreast of current ... one (1) year of analytical development experience + Familiarity with current GMP regulations + The preferred candidate will have proficiency in the qualification… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of industry best practices and trends. + In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. + ... late-stage products. + 1+ year of relevant QC experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory… more
- Amgen (Thousand Oaks, CA)
- …and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant ... GMP system, and support for regulatory audits and responses...+ 6+ years working in a regulated environment (direct GMP ) + 4 years experience managing people and/or leadership… more
- Genentech (Oceanside, CA)
- …Opportunity** + Compliance and Quality System Adherence: Apply advanced knowledge of GMP , GDP, and Data Integrity ALCOA principles daily. Follow established safety ... and proficiency in all necessary wet chemistry methods. + GMP Execution & Compliance: Experience working in a ...GMP Execution & Compliance: Experience working in a GMP environment with the ability to read and follow… more
- ThermoFisher Scientific (Fremont, CA)
- …Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail ... solutions. You'll perform complex manufacturing and formulation activities in a GMP environment, such as producing antibodies using mice and in-vitro equipment… more
- ThermoFisher Scientific (Fremont, CA)
- …are achieved, and production and laboratory standards are in compliance with all GMP , ISO, FDA, OSHA and other company manufacturing and safety guidelines. Ensures ... quality systems are effectively maintained to achieve strong levels of GMP /ISO/FDA/OSHA compliance . Responsible for meeting financial targets, key measurements and… more
- Kelly Services (Torrance, CA)
- …process. + Sanitize and clean equipment and work areas according to GMP and internal protocols. + Maintain accurate documentation, including batch records, equipment ... in real time. + Ensure compliance with FDA and GMP guidelines for OTC manufacturing. + Adhere to all...and/or OTC manufacturing environment. + Solid understanding of FDA, GMP , and SOP requirements in a regulated manufacturing setting.… more