| Job alert | Jobs 1 - 10 of 683 |
Quality Assurance Unit Associate III (FDA, GMP, GLP)
SRI International
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Menlo Park, CA
... This is accomplished through proactive inspections and retrospective data / report audits to ensure that all work is conducted in accordance with FDA regulations, international regulations, protocols, Standard Operating Procedures (SOPs), and ... - Sep 15
Quality Control Analyst
Synthego
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Redwood City, CA
... Maintain complete and accurate production records in conformance with GMP and FDA requirements. Support routine preventive maintenance, general troubleshooting, general cleanliness and calibration of laboratory equipment. Support internal and ... - Sep 21
Manager, Regulatory Affairs, International
Pulmonx Corporation
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Redwood City, CA, 94061
... The Zephyr Valve was granted breakthrough status and approved by the FDA in June 2018, because according to the FDA it “represents a breakthrough technology as the device offers bronchoscopic lung volume reduction without surgery and its associated ... - Sep 12
Associate Director Drug Substance
Meet
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Newark, CA, 94560
... Strong knowledge of FDA/ICH/cGMP guidelines and regulatory CMC filings. Proven leadership with internal and external resources, strategic problem-solving skills, and excellent teamwork. Detail-oriented, self-driven, with strong multitasking ... - Sep 07
Eikon Clinical Community
BioSpace
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Hayward, CA, 94557
... In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's ... - Aug 27
Electrical Engineer I
ICONMA, LLC
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Alameda, CA, 94501
... Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management Top Skills on resume Degree, 5+ years of work exp in medical device industry., FDA / ISO13485. Requirements Bachelor s ... - Sep 17
Staff Microbiology Scientist
Sterling Engineering
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San Jose, CA, 95134
$65-70 / hour
... Ensure compliance with regulatory standards (e.g., FDA, ISO) and comply with biohazard safety standards. Participate in product risk assessment, technical design reviews and critically evaluate design and implementation plans. Summarize findings and ... - Sep 13
Senior Infrastructure Engineer
I.T. Solutions, Inc.
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Alameda, CA, 94501
... and new infrastructure systems and applications Manage patching and remediation of security vulnerabilities in the environment and actively id Follow industry and Exelixis best practices and procedures in a SOX and an FDA regulated environment. ... - Sep 20
Associate Director, Drug Product
Eikon Therapeutics
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Hayward, CA, 94545
... Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.). Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, and BLAs. Interact with regulatory agencies to address CMC-related queries and provide ... - Sep 07
Quality Manager
ATR International
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Milpitas, CA
90000USD - 125000USD per year
... · Directly responsible for the creation and maintenance of the Quality Management System that is in full compliance to the existing (and when needed, future) ISO and regulatory standards such as ISO 9001, ISO 13485, ISO 14001, and/or FDA etc. · Lead ... - Sep 10