Quality Assurance Supervisor

Founded in 1985, Gemini Bio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.

The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers’ manufacturing workflows – regardless of batch size.

Located in West Sacramento, California, Gemini Bio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company’s cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. Gemini Bio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

The QA Supervisor is responsible for overseeing Quality Operations and Scientific Support activities to ensure products, processes, and quality systems comply with regulatory, customer, and company requirements. This role provides leadership and guidance to quality personnel, supports product release decisions, and ensures the timely review and approval of quality records, investigations, and assessments. The position plays a key role in audit and inspection readiness by coordinating audits, supporting regulatory inspections, and driving the resolution of compliance issues.

Additionally, the QA Supervisor develops team members, monitors quality performance metrics, and communicates quality risks, trends, and improvement opportunities to management to support continuous improvement and operational excellence.

• Supervise and provide guidance to QA Operations and Scientific Support personnel to ensure timely execution of quality activities.
• Review and approve quality records, investigations, assessments, and documentation for accuracy, completeness, and compliance.
• Provide escalation support for quality issues, compliance risks, and product disposition decisions.

• Perform product release activities for manufactured, OEM, repackaged products.
• Ensure batch records, completed records, and supporting documentation are reviewed and maintained in accordance with applicable requirements.
• Support decision-making related to product disposition and quality risk assessments.

• Oversee Deviations, Out of Specification (OOS), Nonconforming Material Reports (NMRs), and other Quality Events throughout their lifecycle.
• Ensure customer complaints are investigated, documented, and resolved in a timely manner.
• Provide oversight of supplier qualifications, reassessment, change notification reviews, and supplier quality activities.
• Support continuous improvement initiatives that strengthen quality system effectiveness.

• Coordinate and support customer audits, internal audits, supplier audits and regulatory inspections.
• Review audit responses and ensure timely completion of corrective actions.
• Promote inspection readiness through routine monitoring of quality system compliance.
• Manage workload, priorities, and resource allocation within the QA team and Scientific Support team.
• Coach, mentor, and develop QA team and Scientific Support team.
• Conduct performance evaluations and establish development plans for team members.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

• Prepare and present quality metrics,…