- Astrix Technology (Gardena, CA)
- …Strong attention to detail, patience, and self-motivation + Familiarity with QA or GMP regulations a plusINDBH We are an equal opportunity employer and all qualified ... applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. more
- Astrix Technology (Downey, CA)
- …and collaborate with a Chemist to set up stability studies. + Adhere to GMP procedures and comply with all relevant regulations (eg, FDA). + Calibrate and maintain ... laboratory instruments as necessary. + Prepare volumetric solutions and perform standardization when required. + Maintain accurate documentation and retain samples as needed. + Follow laboratory safety protocols and properly dispose of hazardous waste. + Keep… more
- Astrix Technology (Petaluma, CA)
- …3-5 years of production planning in biotech, pharma, or medical device industries ( GMP -regulated). + Experience with MS Office and ERP systems. + Familiarity with ... CPIM/APICS certification (preferred). INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status,… more
- ThermoFisher Scientific (Palo Alto, CA)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, ... perfume, exposed piercings, facial hair etc allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for… more
- Stryker (Irvine, CA)
- …and International Medical Device Regulations. + Familiarity with ISO 13485, GDP, GMP . + Proven ability to represent Quality across projects, with strong ... communication, problem-solving, critical thinking, and cross-functional collaboration skills in a matrix environment. $100,700 - $165,100 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Health… more
- Vera Therapeutics (Brisbane, CA)
- …etc. Compliance & Regulatory Oversight * Ensure full compliance with FDA, EMA, GMP , GCP, GDP, and SOX regulations across all supply chain activities, including ... vendor compliance. * Oversee clinical trial readiness, including compliant labeling, packaging, and documentation for regulatory submissions. * Maintain audit readiness and lead internal/external audits, CAPA processes, and quality system reviews. * Implement… more
- Amgen (Thousand Oaks, CA)
- …Established expertise and knowledge of Pharmaceutical/Biotech Supply Chain and GMP processes + Project management and/or change management certification (preferred) ... + Strong data analysis and critical thinking skills + Experience with demand planning technology and analytics tools + Deep knowledge of S&OP, forecasting, demand and supply planning + Strategic problem solver with a strong process attitude + Effective… more
- Amgen (Thousand Oaks, CA)
- …across feasibility, development, and verification/qualification phases in a GMP environment. Provide comprehensive data analysis and actionable recommendations ... to support informed decision-making by senior leadership. + Lead/support the authorship and management of regulatory filings, address agency questions, and represent PCE during audits. + Lead/support the impact assessment of new and revised… more
- Astrix Technology (Fremont, CA)
- …training preferred. + Minimum 1 year of experience in a GMP -regulated manufacturing environment (pharmaceutical or biotechnology industry strongly preferred). + ... Basic computer skills (MS Office, Outlook, and other systems). + Strong organizational skills and ability to work in small teams. + Ability to read, comprehend, and follow written instructions. + Demonstrated math proficiency, including basic arithmetic and… more
- CBRE (Irvine, CA)
- …experience with maintenance and CMMS systems such as Maximo. + Preferred GMP biopharmaceutical industry experience in a role related to plant equipment, utilities, ... and systems, of which minimum 2+ years' experience providing support within Facilities department + Ability to use existing procedures to solve standard problems. + Experience with analyzing information and standard practices to make judgements. + In-depth… more