GMP Sample Management & Stability Lead

Asahi Kasei Bioprocess America, Inc.; Fremont (CA); On-site; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Paid time off

Annual bonus eligible

Job summary

Bionova Scientific LLC in Fremont, CA, seeks a QC Supervisor for Sample Management and Stability Administration. You will oversee GMP sample management, maintain sampling plans, study calendars, and documentation, coordinating with QC, QA, Manufacturing, clients and external testing labs.

Leading a small team, you will schedule pulls, ensure traceability, manage deviations/CAPAs, and keep records audit-ready in LIMS and GMP documents.

Qualifications

• BS or higher in physical or biological sciences or related discipline.
• Experience in GMP sample management or stability administration.
• Strong organizational and leadership skills.
• Proficiency with LIMS or other sample tracking systems and GMP documentation.

Responsibilities

• Lead a small team (2–3 staff) and coordinate daily sample management activities.
• Oversee sample receipt, labeling, storage, and disposition per procedures.
• Establish and maintain stability study schedules and pull calendars.
• Generate sampling plans, testing specifications, and stability protocols.
• Maintain traceability, chain of custody, and audit-ready records.

Skills

Leadership

Organization

Communication

GMP knowledge

Education

BS or higher in physical or biological sciences

Tools

LIMS

Spreadsheets

Job description

Bionova Scientific LLC in Fremont, CA, seeks a QC Supervisor for Sample Management and Stability Administration. You will oversee GMP sample management, maintain sampling plans, study calendars, and documentation, coordinating with QC, QA, Manufacturing, clients and external testing labs.

Leading a small team, you will schedule pulls, ensure traceability, manage deviations/CAPAs, and keep records audit-ready in LIMS and GMP documents.