Sample Management

About the role

Performs routine processing and data review of raw materials, in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant laboratory environment.

Responsibilities

• Performs routine inventory and sample management of routine samples, critical reagents, and non-routine samples, including Chain of Custody.
• Executes routine procedures owned by the Sample Management functional area as assigned in the LMS by the hiring manager, based on applicable curricula map(s).
• Works in teams with continual interaction across Quality Control sub-teams to exchange information and meet department goals.
• Daily contact with supervisory staff for work assignments, coaching, and performance management discussions.
• Occasional contact with line management, Manufacturing, Stability organizations, other sites, or vendors for escalations or logistical purposes.
• Maintains high attention to detail while handling hazardous materials and using Personal Protective Equipment (PPE) in a cGMP laboratory.
• Observes work area and tools, identifying and reporting any discrepancies from normal practice or procedure.

Requirements

• Knowledge of science generally attained through studies resulting in an AS or certificate program in physical or life sciences, supply chain, or related discipline, or equivalent experience.
• Knowledge of basic laboratory techniques such as working in a BSC, pipetting, aseptic technique, and laboratory safety practices.
• Familiarity with controlled temperature storage, sample inventory, sample shipment, and receipt.
• Attention to detail and demonstrated organizational skills.
• Demonstrated manual dexterity.
• Proficiency in basic electronic systems (email, MS Office, etc.).

Qualifications

High School Diploma required or currently enrolled in a scientific program.