- WuXi AppTec (San Diego, CA)
- …to optimize existing processes (Process R&D); Perform job-specific tasks in compliance with FDA regulations, Safety Consciousness, internal standards, company ... Plan, execute, and document cGMP and non-GMP/GLP laboratory work supporting regulatory submissions; Assist with Scale up (multi-kg scale) tech transfers from… more
- Medtronic (San Francisco, CA)
- …overnight or occasional flight travel. + Understands and adheres to FDA Regulations, quality and training requirements, SOPs, and Work Instructions-continually ... with clean record and subject to regular driver's license review for compliance purposes. Must Have: Minimum Requirements + Bachelor's degree required + Minimum… more
- Wacker Chemical (San Diego, CA)
- …and techniques as well as a subject matter expert (SME) for metrology. + Ensures compliance with regulatory standards (eg, GMP, ISO 17025). Plays a key role in ... certifications (eg, Certified Calibration Technician by ASQ) + 8-10+ years of experience in a FDA and GMP regulated industry. + ISO 7 & ISO 8 gowning experience is… more
- Cedars-Sinai (Los Angeles, CA)
- …the study. This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case ... budget and patient research billing. This role will follow all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and patient… more
- Cedars-Sinai (Los Angeles, CA)
- …and work with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and local agencies including the Food and Drug ... Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** +...verbal communication skills. + Ability to strictly adhere to regulatory requirements and ethical guidelines. This role is designed… more
- Gilead Sciences, Inc. (Foster City, CA)
- …cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements. + Provide guidance and strategic directions through interactions ... + Hire, mentor and develop team members within the organization + Support regulatory filings by guiding the draft, review, and approval of CMC sections; support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with process scale-up to pilot and manufacturing scale equipment. + Understanding of FDA , EMA, and ICH regulatory guidelines related to cGMP. + Excellent ... external manufacturing facilities. + Adhere to department budget and all training, compliance and safety requirements. + Mentor junior team members on cell culture… more
- Fujifilm (Santa Ana, CA)
- …pharmaceutical or medical devices industry. + Working knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements. + Working experience with ERP system. ... Production documents as well as monitoring the accuracy and completeness to ensure compliance with cGMP and GDP guidelines and company policies. They will also… more
- Danaher Corporation (Brea, CA)
- …product lifecycle and deliver sustained improvements in quality, delivery, cost, and compliance . The essential requirements of the job include: + Bachelor's degree ... plus if you also possess : + Experience in FDA -regulated or medical device manufacturing environments. + Familiarity with...with ISO13485, 21 CFR Part 820, and other relevant regulatory frameworks. The salary range for this role is… more
- Compass Group, North America (San Francisco, CA)
- …policies to implement wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. **Key Responsibilities:** + ... op-in wellness offerings. + Supports account in meeting nutrition related regulatory requirements including federal menu labeling laws, local and state requirements… more