The QC Supervisor, Sample Management and Stability Administration, oversees GMP sample management and administers stability programs to ensure accurate sample tracking, timely testing coordination, and complete, compliant documentation. The role generates and maintains sampling plans, testing specifications, and stability protocols in collaboration with QC, Quality Assurance, Manufacturing, clients, and external testing laboratories. Responsibilities include coordinating sample receipt, storage, distribution, shipment, retention, and disposition; scheduling stability pulls; and tracking testing and documentation deliverables against approved requirements and project timelines.
This supervisory role requires exceptional organizational skills, attention to detail, and the ability to multitask across concurrent projects, sample inventories, stability studies, and competing deadlines. The supervisor establishes priorities, assigns and monitors work, maintains reliable tracking systems, and proactively resolves scheduling conflicts and documentation gaps. The position focuses on sample logistics, stability administration, and cross-functional coordination rather than hands-on analytical testing, method development, or method validation.
Location: Fremont, CA
Benefits
- Direct Hire
- Medical, Dental, Vision, 401K (match up to 5%, plus an additional 3%, total 8%)
- Paid time off
- Annual Bonus eligible
Essential Duties and Responsibilities:
- Sample management and team coordination: Lead a small team of 2-3 staff members, supervise daily sample management activities, and coordinate workloads, staffing coverage, and priorities. Oversee sample receipt, accessioning, labeling, reconciliation, storage, distribution, shipment, retention, and disposition in accordance with approved procedures. Maintain sample traceability, chain of custody, and accurate inventory and location records throughout the sample lifecycle.
- Stability administration: Establish and maintain stability study schedules, sample inventories, storage assignments, and pull calendars. Coordinate study initiation, sample placement, scheduled pulls, testing submissions, and study closure in accordance with approved stability protocols. Track time-point completion and documentation status, communicate upcoming milestones, and promptly escalate missed pulls, storage excursions, or other discrepancies.
- Sampling plans and testing specifications: Generate, revise, and maintain sampling plans and testing specifications in collaboration with relevant manufacturing functions and Quality Assurance. Define sample types, quantities, containers, sampling points, storage and shipping conditions, required tests, and applicable acceptance criteria based on approved requirements. Coordinate review and approval, maintain version control, and ensure current documents are available before sampling and testing activities begin.
- Stability protocols and records: Generate, revise, and maintain stability protocols defining study design, storage conditions, time points, sample quantities, testing requirements, and applicable acceptance criteria in alignment with approved program requirements. Coordinate protocol review, approval, and amendments; maintain study records; and compile testing results and supporting documentation for review by designated technical and quality personnel.
- GMP documentation and systems: Author, revise, and review SOPs, forms, and records supporting sample management and stability administration. Maintain accurate, timely entries in LIMS or other approved tracking systems, reconcile records with physical inventories, and review documentation for completeness and traceability. Support document approval within assigned authority and maintain organized, readily retrieva