Manufacturing Associate 1st Shift Monday - Friday 1st Shift Wednesday - Sunday 2nd Shift - Monday - Friday Role Overview: The Manufacturing Associate will perform all activities involved in the aseptic processing of a biologic product, under the direct supervision of the Manufacturing Supervisor. This position will support the Manufacturing department by performing tasks that will assure the safe and timely processing of the product, working in a classified GMP environment. Responsibilities: - Prepare product, according to production planning and GMP regulations. Initiate, create, and review batch records and labels and perform regular checks on the process, following batch records, in order to product to according to GMPs (10%) - Responsible for manufacturing a cell-based product according to established Master Batch Records and Operating Procedures (10 %) - Responsible for the preparation and in-process testing of all media, reagents, substrates for testing, and sanitizing agents used in manufacturing areas (10 %) - Responsible for proper operation of all clean room equipment. Assist with maintenance and equipment validation as needed (10 %) - Prepare, author, and execute procedural SOP'S, specifications, protocols, data analyses, and technical reports, as needed. (10 %) - Responsible for assuring Standard Operating Procedures and Batch Records are complete and compliant in alignment with processing (10 %) - Responsible for maintaining all required records to established guidelines for production procedures, the GMPs, and safety. (10 %) - Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, the GMPs, and the safety guidelines. (15 %) - Responsible for conducting on-the-job training for incoming Manufacturing Operators (5 %) - Regularly execute performance checks on the assigned production apparatus in order to signal defects as soon as possible. Participate in environmental monitoring and process validation, when applicable (5 %) - Perform other duties as required (5 %) Location: Fort Worth, Texas Education: High school diploma or GED required. Bachelor of Science in Biology or other Life Science focus is preferred. Licenses/ Certifications: None Experience: 2-5 years experience (cell science experience is preferred) Competences: GMP experience is required Regulated industry experience is required Physical Demands: Ability to lift up to 30 lbs. Stand or sit for extended periods of time The ability to change into a cleanroom gown Travel Requirements: No travel required Smith Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.