Reagent Manufacturing Associate

Guardant Health•Redwood City, CA

10d•$30 - $41•Hybrid

About The Position

The Reagent Manufacturing Associate (RMA) I is responsible for manufacturing reagents, assembling kits, and qualification of assigned reagents following Good Manufacturing Practices and documenting events following current Good Documentation Practices.

Requirements

High School Diploma with 4 years of experience in related field; OR Minimum of Associate degree or equivalent; OR Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred.
Guardant Health Clinical Laboratory experience or equivalent high complexity and volume laboratory experience preferred.
Previous laboratory work experience preferred.
Previous GMP laboratory work experience preferred.
Ability to proactively communicate consistently, clearly, and honestly.
Strong computing skills.
Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
Able to integrate and apply feedback in a professional manner.
Ability to work as part of a team.
Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Responsibilities

Manufacture reagents, assemble kits, and qualify assigned reagents according to SOP;
Document reagent manufacturing activities following cGMP;
Perform equipment maintenance according to the laboratory’s standard operating procedures;
Maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties;
Clean racks and other laboratory supplies;
Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications;
Perform clerical work and maintain Reagent Manufacturing and Quality Control documents as necessary;
Assist with managing and ensuring sufficient inventory of reagents in the laboratories of Clinical Operations;
Assist with troubleshooting of manufactured reagents;
Assist in the revision and development of reagent manufacturing SOPs and forms;
Participate in interdepartmental activities with Clinical Operations, Quality Assurance, Quality Control and Supply Chain Management to ensure qualified reagents are available for use at all times;
Assist in the inspection preparation activities as needed;
Perform other duties as assigned;
Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer.