QC Sample Specialist

Role Responsibilities

• Perform Sample Management aspects (Sample receipt, control, and disposal of samples)
• Perform Stability and Reference Standard study/protocol generation
• Perform stability and reference standard pulls
• Maintain stability, lot release, reserve, and retention sample inventory
• Perform preventative maintenance on stability/sample chambers
• Perform domestic and international shipments of samples and critical materials
• Interact with other departments on a regular basis
• Participation in laboratory project initiatives such as 5S, LEAN, and Six Sigma
• Participate in 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

Note: The QC Sample Management Specialist may be required to work on holidays and/or scheduled manufacturing shutdown operations to support business needs.

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