QC Sample Specialist

Role Responsibilities

• Perform Sample Management aspects (Sample receipt, control, and disposal of samples)
• Perform Stability and Reference Standard study/protocol generation
• Maintain stability, lot release, reserve, retention sample inventory
• Perform preventative maintenance on stability/sample chambers.
• Perform domestic and international shipments of samples and critical materials
• Interacts with other departments on a regular basis
• Participation in laboratory project initiatives such as 5S, LEAN, and Six Sigma
• Perform inspection readiness, regulatory inspection support and self-inspection activities
• Perform Quality System attributes such as but not limited to (i.e. Minor Deviations, CAPAs, Change Controls, Action Items)
• Other duties as assigned

Experience Required

• At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Demonstrates the ability to work independently.

Education Required

• A.S./B.A. in Science (major in biology-biochemistry-chemistry).
• 1-2 years of relevant laboratory experience or A.S. with at least 4 years of relevant laboratory experience is desired.