- 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
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** + BA/BS required. Biological science or… 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
- 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
- Mentor Technical Group (South San Francisco, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Hologic (San Diego, CA)
- …documentation, including development and notebook studies for operations. + Participates in FDA , ISO lab audits and performs BSL3 audits. + May represent group ... as extended core team member on one or more core teams or on other teams. + Interfaces with R&D to learn new process and transfers knowledge to department. Reviews and approves process transfer reports, as required. + Performs feasibility studies and assists… more