Summary:

Vaxcyte is seeking a detail-oriented and motivated Sample Management Specialist to join our team. This entry- to mid-level role is responsible for overseeing and executing all aspects of the sample management process — from receipt at the warehouse through storage, distribution, and inventory management. The successful candidate will work cross-functionally with Analytical and Process Development, Materials Management, Quality Assurance, and Operations teams to ensure samples are handled, tracked, and maintained in full compliance with applicable SOPs, Good Documentation Practices, and GMP/GLP regulatory expectations.

Essential Functions:

• Receive sample shipments from Shipping & Receiving following formal handoff procedures, ensuring accurate and timely transfer of custody.
• Perform comprehensive sample intake activities including packing list verification, sample identification checks, sample integrity inspection, and documentation of any discrepancies or issues.
• Coordinate temperature monitoring documentation and all associated shipment records to support data integrity and regulatory compliance.
• Register and maintain sample records within Benchling or other approved sample tracking systems, ensuring entries are accurate, complete, and current.
• Apply and maintain sample labels and associated tracking documentation throughout the sample lifecycle.
• Assign and maintain controlled sample storage locations across multiple temperature conditions to ensure proper organization and accessibility.
• Store and retrieve samples from controlled storage units spanning 2–8°C, -20°C, and -80°C environments in accordance with approved procedures.
• Coordinate the distribution of samples to laboratory groups according to approved sampling plans and requests, maintaining clear chain-of-custody at all times.
• Maintain sample movement logs and chain-of-custody documentation from receipt through final disposition.
• Manage retained sample inventory including long-term storage tracking and coordination of controlled disposal activities.
• Support deviation investigations, temperature excursion events, and sample discrepancy resolution in close collaboration with QA and laboratory teams.
• Perform periodic inventory reconciliation and support sample traceability checks to ensure records remain accurate and audit-ready.
• Support internal audits, inspections, and QA oversight activities related to sample management operations.
• Ensure all sample handling activities are performed in accordance with approved SOPs, Good Documentation Practices (GDP), and applicable regulatory expectations.
• Maintain safe working practices at all times when handling temperature-controlled and potentially biohazardous materials.

Requirements: 

• Bachelor's degree in a life sciences discipline (Biology, Biochemistry, Chemistry, or related field), or equivalent combination of education and relevant work experience.
• Minimum of 3 years of experience in a biotech, pharmaceutical, or clinical laboratory setting.
• Foundational knowledge of GMP and/or GLP principles, including experience reading, following, and contributing to standard operating procedures.
• Familiarity with Good Documentation Practices (GDP) and the importance of data integrity in a regulated environment.
• Experience working in or with temperature-controlled storage environments (refrigerated, frozen, and/or ultra-low temperature conditions).
• Strong attention to detail and organizational skills with the ability to manage multiple samples and priorities simultaneously.
• Effective written and verbal communication skills for cross-functional collaboration with QA, laboratory, and operations teams.

Preferred: 

• Experience with electronic sample or laboratory tracking systems such as Benchling, LIMS, or comparable platforms.
• Exposure to deviation or CAPA processes and supporting documentation.
• Experience following SOPs and making process suggestions/improvements, where appropriate.
• Familiarity with biohazardous material handling protocols and associated safety requirements.