| CMC Quality Consultant at Alameda, California, USA |
| Email: [email protected] |
| From: Priyanka, STELLENT IT [email protected] Reply to: [email protected] Job Title CMC Quality Consultant Location Alameda, California(Hybrid) Duration Long term Job Description They must have CMC Quality experience with analytical quality and biologics. CMC Quality SME needed for analytical quality support and guidance for a thriving biotech innovator. DUTIES & RESPONSIBILITIES: * CMC Analytical Quality collaboration, guidance, oversight & support, including analytical data review, analytical document review, analytical method validations, stability protocols and related approvals, etc. * Support related audits of CMOs and labs for GMP compliance * Quality and Risk assessments and related mitigations * Other duties, as required QUALIFICATIONS & REQUIREMENTS: * 10 years of relevant CMC analytical quality experience with significant focus on biologics * Proven effectiveness in leading and/or influencing change management * Deep and current understanding of relevant global regulations and guidelines, and successful experience interacting with inspection and audit personnel * Relevant BS degree Keywords: information technology |
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| Thu Nov 30 03:00:00 UTC 2023 |