Reagent Manufacturing Associate
Guardant Health | Redwood City | www.resume-library.com |
Job Description
About the Role:
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.
Essential Duties and 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; and
Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer.
About the Role:
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.
Essential Duties and 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; and
Report all concerns of test quality and/or safety to the Laboratory Supervisor, Laboratory Director or Safety Officer.
Don’t miss out on new job openings!
Create a job alert for: Supply Chain Manager, Cupertino
It's free, and you can cancel email updates at any time