Quality Assurance Supervisor | cGMP & Audit Readiness

GeminiBio LLC.; Sacramento (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

GeminiBio LLC. is seeking a QA Supervisor in West Sacramento, CA to lead QA Operations and Scientific Support, ensuring products and processes meet regulatory and customer requirements. The role oversees release decisions, quality records review, and improvement initiatives.

You will mentor QA and Scientific Support staff, drive audit readiness, manage deviations and CAPA, and report quality metrics to management to sustain compliance and continuous improvement.

Qualifications

• Bachelor’s degree in science; 5+ years in cGMP QA; 2+ years leadership experience.
• Deep knowledge of GMP regulations and quality systems.
• Experience with supplier qualification, deviations, and CAPA processes.

Responsibilities

• QA Operations & Scientific Support oversight to ensure timely quality activities.
• Perform product release activities and ensure documentation is complete and compliant.
• Oversee Deviations, OOS, NMRs, and other Quality Events throughout their lifecycle.
• Coordinate and support customer and regulatory audits and inspections.
• Prepare quality metrics and reports for management reviews.

Skills

Leadership

Quality systems

Audits

GMP

Regulatory knowledge

Education

Bachelor’s degree in science

5+ years cGMP QA

2+ years leadership

Job description

GeminiBio LLC. is seeking a QA Supervisor in West Sacramento, CA to lead QA Operations and Scientific Support, ensuring products and processes meet regulatory and customer requirements. The role oversees release decisions, quality records review, and improvement initiatives.

You will mentor QA and Scientific Support staff, drive audit readiness, manage deviations and CAPA, and report quality metrics to management to sustain compliance and continuous improvement.