QC Supervisor, Sample Management and Stability Administration

Asahi Kasei•Fremont, CA

3d•Onsite

About The Position

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. It coordinates sample receipt, storage, distribution, shipment, retention, and disposition; schedules stability pulls; and tracks testing and documentation deliverables against approved requirements and project timelines. This supervisory role leads a small team of 2–3 staff members and requires exceptional organization, attention to detail, and the ability to manage 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. The role is based in Fremont, California, and involves work in laboratory and office settings. The base compensation range is $120,000–$140,000. The position is direct hire and is eligible for an annual bonus.

Requirements

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, with a strong quality mindset and meticulous attention to detail.
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 demonstrated 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 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.

Responsibilities

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.
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, or other discrepancies.
Generate, revise, and maintain sampling plans and testing specifications with relevant manufacturing functions and Quality Assurance, defining sample types, quantities, containers, sampling points, storage and shipping conditions, required tests, and applicable acceptance criteria based on approved requirements.
Coordinate review and approval of sampling plans and testing specifications, maintain version control, and ensure current documents are available before sampling and testing activities begin.
Generate, revise, and maintain stability protocols; coordinate protocol reviews, approvals, and amendments; maintain study records; and compile testing results and supporting documentation for review by designated technical and quality personnel.
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 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 work, monitor progress, and adjust assignments as needed.
Identify conflicting requirements early and escalate risks to sample integrity, compliance, or timelines.
Serve as a primary contact for sample logistics and stability administration; 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 associated 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.