Qc Manager California Jobs

USA: Quality Control

Top notch Global Biotech company is looking for a Quality Control Manager.

Expert in:

✅method transfers

✅validation / verification

✅cleaning validation

Responsibilities:

• Participates and supports regulatory audits
• Works closely with site and global analytical teams to ensure compliance with regulatory updates
• Leads method transfers, method verifications, and method validations
• Maintains site test methods and critical reagents, including periodic review, trending, and extension
• Manages capital projects and operating budgets for the team
• Attends project team meetings as the QC representative and works closely with the team to ensure on-time delivery
• Creates, revises, and reviews quality GMP documents, i.e., local SOPs and assay worksheets
• Performs qualification and validation of analytical equipment
• Performs technical studies for key stakeholders such as manufacturing, MSAT, and external customers

Requirements:

• 8+ years of experience in analytical / QC testing in sterile pharmaceutical or biopharmaceutical laboratories in a GMP environment
• Preferred experience in ELISA, qPCR, CESDS, HPLC, and icIEF
• Bachelor's degree and/or advanced graduate degree (MS/PhD)
• Advanced experience with method validation, method transfer, and method troubleshooting
• Minimum 3 years’ experience in management (supervisor and above)

This role comes with $145,000/yr - $150,000/yr base salary and a generous benefits package.

Please note that the job is currently open to US residents and Green Card holders.