Quality Assurance Quality Control (QA-QC) Inspector II

Job Title

Responsible for, but not limited to, inspecting, and receiving human and porcine tissue, batch record review, cleaning, cycle count, product/tissue quarantine, media change and disposition activities. Ensures quarantine, receiving, cycle count, cleaning, media change and review activities are performed in accordance with all applicable procedures, regulations, and established specification requirements. This position is required to support overall departmental needs such as data trending, audit SME support, documentation updates among other tasks. Provide technical support to teams and cross-functional teams to ensure effective operations. Proficient in all areas of QC Tissue Receipt. This role is also responsible for identifying, coordinating, and implementing 5S and Lean Six Sigma continuous improvements initiatives.

Skills: Adaptability, Attention to detail, Critical Thinking and Problem solving, Communication, Decision Making

Other Professional Skills: 5+ years of experience in a cGMPs, GDP, ISO, FDA regulated industry preferred. Advanced Computer Skills-High knowledge and understanding of Windows based computer systems. cGMPs, AATB Standards, ISO, FDA and USP regulatory guidelines SAP (ERP) Basic knowledge of statistical techniques and quality tools.

Job Qualification Ability to carry and lift boxes weighing up to 50 lbs. Ability to work varied schedule with some potential weekend, early morning or late evening hours, if needed. Ability to work with human and porcine raw materials and finished goods specifically defined functional areas. Must be comfortable working in a lab, warehouse and manufacturing settings. Willing to work with potentially biohazardous materials, including cadaveric tissue. Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time. Ability to carry out detailed written or oral instructions. Ability to handle a wide variety of tasks under critical time constraints. Computer proficiency and scheduling experience required; good writing skills required.