QA Operations Lead – cGMP Biotech

GeminiBio LLC.; West Sacramento (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

GeminiBio LLC in West Sacramento, CA is hiring a QA Supervisor to lead Quality Operations and Scientific Support, ensuring products and processes meet regulatory and customer standards. You will guide releases, investigations, and continuous improvement while developing team capabilities and maintaining audit readiness.

The role oversees deviations, OOS/NMRs, supplier quality, customer complaints, and quality metrics reporting to senior management, fostering a culture of accountability and

Qualifications

• Bachelor’s degree in science and 5+ years working in a cGMP Quality Management System with at least 2 years leadership experience
• Knowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485)
• Independent problem solving and root cause analysis skills
• Skilled with auditing principles
• Self-motivated who can work in a multidisciplinary team
• Excellent at multitasking and prioritization of tasks
• Strong interpersonal skills to collaborate with other cross-functional partners
• Aptitude to work in a complex and rapidly growing company
• Ability to develop and deliver communications to provide timely information for action
• Must be highly accurate and detail-oriented
• Knowledge of Microsoft Office products
• Excellent oral and written communication skills

Responsibilities

• Oversee QA Operations and Scientific Support to ensure timely quality activities
• Review quality records, investigations, and documentation for accuracy and compliance
• Provide escalation support for quality issues and product disposition decisions
• Perform product release activities and ensure proper documentation for releases
• Oversee deviations, OOS, NMRs, and other quality events throughout their lifecycle
• Coordinate customer, internal, supplier, and regulatory audits and inspections
• Promote quality system improvements and management reporting of metrics
• Coach and develop QA and Scientific Support teams

Skills

Bachelor degree in science

Leadership experience

cGMP quality systems

Root cause analysis

Auditing principles

Multitasking & prioritization

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor’s degree in science

Job description

GeminiBio LLC in West Sacramento, CA is hiring a QA Supervisor to lead Quality Operations and Scientific Support, ensuring products and processes meet regulatory and customer standards. You will guide releases, investigations, and continuous improvement while developing team capabilities and maintaining audit readiness.

The role oversees deviations, OOS/NMRs, supplier quality, customer complaints, and quality metrics reporting to senior management, fostering a culture of accountability and