QC Supervisor, Sample Management and Stability Administration

Asahi Kasei•Fremont, CA

1d•$120,000 - $140,000•Onsite

About The Position

Bionova Scientific LLC, a biologics CDMO and subsidiary of Asahi Kasei Medical, is seeking a QC Supervisor, Sample Management and Stability Administration in Fremont, California. The role oversees GMP sample management and stability program administration to ensure accurate sample tracking, timely testing coordination, and complete, compliant documentation. The supervisor develops and maintains sampling plans, testing specifications, and stability protocols in collaboration with QC, Quality Assurance, Manufacturing, clients, and external testing laboratories. The position coordinates sample receipt, accessioning, labeling, reconciliation, storage, distribution, shipment, retention, and disposition; schedules stability pulls; and tracks testing and documentation deliverables against approved requirements and timelines. It leads a small team of 2–3 staff members and manages workloads, priorities, tracking systems, deadlines, and scheduling conflicts across concurrent projects. The focus is sample logistics, stability administration, and cross-functional coordination—not hands-on analytical testing, method development, or method validation. The role is based in laboratory and office settings. Duties may involve walking, standing, stooping, kneeling, crouching, and occasional independent lifting or moving of up to 20 pounds. The base compensation range is $120,000–$140,000. The position is direct hire and eligible for an annual bonus.

Requirements

A BS or higher in physical or biological sciences or a related discipline, or equivalent relevant industry experience.
Demonstrated experience in GMP sample management, stability administration, or closely related QC operations.
Experience managing sample inventories, traceability, chain of custody, storage requirements, testing submissions, and shipments.
Experience generating and maintaining sampling plans, testing specifications, stability protocols, and study schedules.
Proficiency with LIMS or other sample tracking systems, spreadsheets, and controlled GMP documentation.
Knowledge of GMP documentation, data integrity, and sample traceability requirements.
Ability to identify discrepancies, support investigations and CAPAs, and maintain complete, accurate, inspection-ready records.
Experience leading a small team of 2–3 staff members is required.
Exceptional organizational, planning, and time-management skills, including the ability to coordinate multiple projects, maintain detailed schedules and trackers, and meet competing deadlines without compromising accuracy.
Ability to reprioritize effectively, anticipate dependencies, delegate work, supervise daily activities, and maintain consistent follow-through across functional teams.
Effective verbal and written communication skills, including the ability to prepare clear sampling plans, testing specifications, stability protocols, and status updates.
Ability to coordinate requirements with clients, internal teams, and external laboratories; communicate changing priorities promptly; and resolve scheduling and documentation issues collaboratively.
Ability to perform duties involving walking, standing, stooping, kneeling, crouching, and occasional independent lifting or moving of up to 20 pounds.

Responsibilities

Lead a small team of 2–3 staff members and supervise daily sample management activities, 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.
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 escalate missed pulls, storage excursions, and other discrepancies.
Generate, revise, and maintain sampling plans and testing specifications in collaboration with 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 document review and approval, maintain version control, and ensure current documents are available before sampling and testing activities begin.
Generate, revise, and maintain stability protocols; coordinate protocol review, approval, and amendments; maintain study records; and compile testing results and supporting documentation for review.
Author, revise, and review SOPs, forms, and records supporting sample management and stability administration.
Maintain timely and accurate 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 retrievable records for audits and inspections.
Manage concurrent sample requests, stability studies, shipments, and documentation deliverables using schedules, trackers, and follow-up processes.
Anticipate workload peaks, prioritize by due dates and project needs, monitor progress, adjust assignments, and escalate risks to sample integrity, compliance, or timelines.
Coordinate sampling requirements, testing submissions, external laboratory shipments, turnaround times, and documentation deliverables with internal departments, clients, and contract laboratories.
Provide clear status updates, track outstanding actions, and follow through to closure without taking responsibility for analytical testing execution.
Lead or support investigations related to sample handling, inventory discrepancies, storage conditions, stability scheduling, and documentation errors.
Coordinate related change controls and CAPAs, assess impacts with appropriate technical and quality personnel, and track actions to completion.
Train staff on sample management and stability procedures and improve workflows to strengthen compliance, accuracy, and operational efficiency.