- Amgen (Thousand Oaks, CA)
- …toxicology approaches + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements + ... Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication + Ability to analyze and interpret complex datasets + Exercises initiative in meeting goals and drives innovation in projects They will… more
- Charles River Laboratories (Redwood City, CA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …and execute a comprehensive audit strategy aligned with global regulatory expectations ( FDA , EMA, MHRA, PMDA, PIC/S) and Kite's quality objectives. Ensure risk-based ... coverage across internal operations, suppliers, and contract manufacturers. + **Audit Execution & Oversight:** Oversee the planning, execution, and reporting of audits across all GMP subsystems, including Quality Systems, Production, Facilities & Equipment,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …**Qualifications** + Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of ... current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are… more
- Stryker (San Jose, CA)
- …Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements + Demonstrated expertise in regulatory systems ... in a regulated environment + Demonstrated ability to manage complex projects + Demonstrated verbal, written, and interpersonal communication skills + Demonstrated ability to work in a team environment, interact effectively with management from other functions… more
- CSL Plasma (National City, CA)
- …donor disconnect. + In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more
- ThermoFisher Scientific (San Francisco, CA)
- …Skills, Abilities** + Demonstrable understanding of applicable regulatory requirements (ISO, ICH, FDA , EMA and USP) as it relates to analytical method transfer, ... phase-appropriate analytical method qualification and validation, safety testing and drug product stability. + Ability to build, use, and interpret scientific tables, charts, and graphs. + Able to read, comprehend, and make appropriate alterations to documents… more
- Moonlight Companies (Reedley, CA)
- …Qualifications and Skills Required: + Bilingual (Spanish/English) + Prior Knowledge/Experience of FDA , GMP, GAP, HACCP, USDA helpful + Ability to work well in ... a team-based environment with limited supervision + Ability to work in a fast paced environment + Proficiency with basic computer skills, including e-mail, Microsoft Office Pay Range ($16.50 min - $17.00 max)/hour Powered by JazzHR more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …experience is also required. + Minimum 4+ years of relevant experience in a FDA regulated industry including a minimum of 2 years of experience in training, ... education or related area or a combination of relevant work experience and education. The estimated pay scale for the Technical Training Specialist role based in Los Angeles, CA , is $80,500 - $93,500 per year. Additionally, the position is eligible to… more
- Abbott (Pleasanton, CA)
- …supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA , ISO 13485). + **Develop and manage detailed project plans** , ... timelines, budgets, and deliverables with a focus on supplier performance and risk mitigation. + **Monitor supplier quality metrics** and project progress, proactively identifying issues and implementing corrective actions to maintain compliance and minimize… more