|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.
Responsibilities for Contract QA Consultant
Qualifications required for Temp QA role
- 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.
Start date: ASAP
- 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.
Please send resumes to luke.newton(at)epmscientific.com
Consultant Senior QA Specialist / QA Manager - Menlo Park - Biotech