Posted to MedZilla on 2/16/2020

Phaidon International

US-CA, Consultant Senior QA Specialist / QA Manager - Menlo Park - Biotech 452431239785-MZ


Consultant Senior QA Specialist / QA Manager - Menlo Park - Biotech

EPM Scientific seeks a temporary / consultant Senior QA Specialist / QA Manager to support our client’s Quality Assurance program.  This is a full-time consultant position for 6 to 8 months.

•Maintain cGMP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policy.
• Ensure contract manufacturing and analytical testing are performed in accordance with applicable company procedures and are in compliance with all applicable regulatory requirements.
• Manage/conduct quality audits various manufacturing and testing vendors.
•Manage/conduct quality audits of manufacturing and testing records, which include master and executed batch records, method validation protocols and reports, stability and release testing data, specifications, and other controlled documents as required.

•5+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems 
•3+ years hands-on cGMP/GLP Compliance experience 
•B.S./M.S. in relevant science field
•Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing cGMP and GLP operations.
•Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.

Start date: ASAP 

Please send resumes to luke.newton(at) 

Consultant Senior QA Specialist / QA Manager - Menlo Park - Biotech

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