Quality Assurance Analyst II

Company: Integrated Resources
Location: Cordova
Posted on: March 18, 2023

Job Description:

Job Description JOB DESCRIPTION Memphis Quality Department employed to perform birth tissue donor record reviews and ensure safe and eligible birth tissue donors are released to manufacturing. Donor Eligibility Coordinator will be responsible for creating and maintaining all types of tissue donor records, requesting and reviewing donor records/laboratory results, sending the Medical Director all required donor information in order to safely determine donor eligibility, ensuring all required sign-offs are completed prior to release of the donor to manufacturing, updating all donor logs/databases to ensure they are current, notifying applicable departments of donor status, etc. Donor Eligibility Coordinator will ensure full compliance with the Quality Management System (QMS) as required by 21 CFR Part 1271, AATB Standards, State Requirements and Company's Operating Procedures. RESPONSIBILITIES Birth tissue donor eligibility reviews and release Gather and assemble all donor records sent to company's - Member. Create and label donor record file Request missing information or corrections to donor information from recovery/acquisition establishments as needed. Request and review serological and microbiological test results Prepare donor packet and donor eligibility determination documents for the Medical Director and submit when ready. Obtain Medical Directors completed documents, complete review, and submit to Director of Quality or designee for final review and sign-off. Log donors into all applicable databases. All databases/logs MUST be current at all times. Send donor information to appropriate staff in order notify manufacturing and quality departments of the donor status. Maintain all donor records in a controlled and secured location File donor records appropriately Review donor for acceptance as requested by management ssist in receiving and inspecting incoming donor tissue as needed. Prepare trends and graphs. Maintaining and provide donor metrics to management. ssist in creating/revising policies, procedures, specifications and forms for Donor Eligibility program. Maintain up to date knowledge with respect to relevant donor eligibility and donor recovery/acquisition. Perform donor screening and acceptance tasks (i.e. functioning as on-call coordinator, replying to emails, texts, phone calls, etc.) if contacted by the recovery/acquisition establishments Coordinate donor tissue shipments as instructed by management. ny other duties or responsibilities necessary or as assigned. REQUIRED SKILLS & KNOWLEDGE BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) or equivalent education/experience with at least 1 year of tissue/ocular donor record review experience or a High School diploma with at least 4 years of experience in tissue/ocular donor record review. Knowledge of AATB Standards and 21 CFR 1271 regulations. Preferably CTBS or CEBT certified. Experienced and proficient with Excel and Word programs. Organized, attention to detail and maintain appropriate analytical skills. Experience in applying statistical methods for quality improvements. Organized file management. Strong communication skills, both written and verbal. Professional team player ble to lift 40 lbs.

Keywords: Integrated Resources, Memphis , Quality Assurance Analyst II, Professions , Cordova, Tennessee