QC Sample Management Technician - Site based, Redmond, WA

Role Summary

QC Sample Management Technician – Site based, Redmond, WA. Responsible for the movement and control of QC samples and materials, including in-process, drug substance/product, characterization, retain, and stability samples processed through the QC laboratories at the Seattle and Redmond GMP facilities, to support GMP manufacturing activities for biotherapeutic products.

Responsibilities

• Perform routine and non-routine QC sample management operations; handle test samples throughout the sample lifecycle: receipt, storage, distribution, transfer, and disposal. Facilitate cold chain transfers of samples.
• Ensure samples and materials are appropriately labelled and maintain sample tracking, labelling and chain of custody records in accordance with regulatory requirements and written procedures.
• Maintain inventory and distribution of QC samples and materials to functional groups as scheduled or requested. Record performance metrics for the sample management group.
• Support identification and implementation of process efficiencies.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Maintain laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activities.
• Perform all work in compliance with site quality and safety guidelines.
• Must demonstrate flexibility in adjusting to changing priorities and schedules.
• Perform other related duties as assigned.

Qualifications

• Required: Associate’s degree or completion of college-level life science courses.
• Required: Knowledge of basic electronic systems (email, MS Office, etc.).
• Preferred: Knowledge of regulatory standards as they apply to GMP laboratories.
• Required: Attention to detail and demonstrated organizational skills.
• Required: Ability to adapt and adjust to changing priorities and to manage assignments with challenging/conflicting deadlines.
• Required: Ability to work in a high-paced team environment and meet deadlines.
• Required: Ability to communicate effectively with peers and department management.
• Required: Strong adherence to data integrity requirements.
• Required: Travel between Seattle and Redmond site.
• Required: Stand or sit for long periods of time while performing duties.
• Required: Ability to use various cleaning and disinfectant agents.
• Required: Ability to lift heavy objects (up to 50 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach without accommodation.

Education

• Associate’s degree or completion of college-level life science courses.