Principal QA Consultant at Lumicity in San Jose, California

Job Description:

Client: Biotechnology Company

Project Details:

• 6-Month contract
• 40 hours per week.
• Bi-weekly on-site requirement

Key Responsibilities:

• Provide quality oversight of outsourced GMP operations (CMC, CDMO, contract labs).
• Review and approve/reject policies, batch records, test methods, and change controls.
• Perform lot disposition of drug substances, products, and clinical materials.
• Support investigations, deviations, and CAPAs to ensure compliance.
• Assist with regulatory audits and vendor qualifications.
• Present quality metrics and drive continuous improvement initiatives.

Requirements:

• Bachelor's degree in molecular biology, biochemistry, or related field (Master's preferred).
• 10+ years of QA management experience in biotechnology or medical devices.
• Strong knowledge of cGMPs, FDA, and international regulations.
• Excellent communication, organization, and mentoring skills.

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