Quality Assurance Quality Control (Qa-Qc) Inspector II

Description: They will work a Tuesday to Saturday schedule. Dayshift will be 8 to 4:30 on week1 . The second week everything will remain the same Wednesday through Saturday 8 to 4:30 but the Tuesday will be the 12 to 8:30. We are only alternating the Tuesday 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 knowleged of statistical techniquies 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 specicially defined functional areas. Must be comfortable working in a lab, warehouse and manufacturing settings. Willing to work with potentially biohazardess materials, including cadaveric tissue. Ability to walk, lift, bend, squat, stoop, stretch, sit and stand for long periods of time. Ability to carryout 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. To provide some additional information related to the role, we do not perform environmental/histological/microbial testing. This role performs visual inspection for incoming cadaver tissue and performs a subsequent review to ensure specification requirements are acceptable for further processing. This role also performs data entries on paper batch records as well as SAP (ERP), Quarantine activities related to Client s (ER), cycle count, inventory management, Cross-functional communication across multiple departments etc.