QC Supervisor, Sample Management and Stability Administration

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Bionova Scientific LLC

Job Description:

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 retrievable records for audits and inspections.
- Organization, multitasking, and deadline management: Manage multiple concurrent sample requests, stability studies, shipments, and documentation deliverables using structured schedules, trackers, and follow-up processes. Anticipate workload peaks, establish priorities based on due dates and project needs, monitor progress, and adjust assignments as priorities change. Identify conflicting requirements early and escalate risks to sample integrity, compliance, or timelines.
- Cross-functional and client coordination: 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. Communicate clear status updates, track outstanding actions, and follow through to closure without assuming responsibility for execution of analytical testing.
- Deviations, training, and continuous improvement: 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.

Working Conditions:

- Work in laboratory and office settings, with duties involving walking, standing, stooping, kneeling, and crouching, and occasional independent lifting or moving of up to 20 pounds.

Qualifications:

- Education or experience: BS or higher in physical or biological sciences or a related discipline, or equivalent relevant industry experience, with demonstrated experience in GMP sample management, stability administration, or closely related QC operations.
- Sample management and stability knowledge: 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.
- Quality focus: Strong quality mindset and meticulous attention to detail, with 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.
- Organization, multitasking, and leadership: Experience leading a small team of 2–3 staff members is required. Exceptional organizational, planning, and time-management skills, with 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.
- Communication and collaboration: 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.

The base compensation range for this role is $120,000-$140,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

#LI-MG1

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.