Biotech Quality Manager
Our client is an internationally recognized and respected biotech company focused on industry excellence and breakthroughs in scientific development. With a strong internal R&D department, impressive co-ops with other industry leaders, and proprietary technologies, we work to improve the quality of life on a daily basis. We will utilize your skills as a Biotech Quality Manager as we step forward into unchartered territory!

Responsibilities:

• 7+ years industry experience
• Improve Quality System by identifying gaps and developing CAPAs
• Develop and ensure accordance with regulatory documents, SOPs and batch records
• Supervise and administer the Quality Management System to maintain ISO Certification
• Lead and conduct internal audits for PP, QC, GM as required
• Conduct QMS training
• Monitor and control CPARs and NCRs
• Manage QC lab as needed
• Lead facility to higher levels of certification

• Education: Bachelor’s in scientific discipline required; Master's or PhD preferred
• Experience implementing, managing, and improving Quality Systems
• Understanding of GMP, ISO, FDA regulations and root cause analysis
• Strong working knowledge of protein and endotoxin assays and analytical methods such as ELISA, Western Blot, HPLC-SEC, RP-HPLC, and SDS-PAGE
• Background in reporting to maintain accurate records (SOPs, batch records, regulatory documents)
• Knowledge of aseptic processes

Benefits

Candidates must be legally authorized to work in the United States.