US - Manufacturing Associate-Jr TX

3 weeks ago

fort worth, United States TalentBurst Full time
Title US - Manufacturing Associate-Jr
Location : Fort Worth, TX 76
Responsibilities
Summary 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. Essential Functions Position Functions (Include no more than 10 functions) % of Position 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 produce according to the 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 the 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 SOPs, specifications, protocols, data analyses, and technical reports, as needed. 10 Responsible for assuring Standard Operating Procedures and Batch Records are complete and are 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. 5 Perform other duties as required.
5 Requirements Travel: No travel required Education:
High school diploma or GED required. Bachelors of Science degree in Biology or other Life Science focus is preferred. Licenses/Certifications: None Experience: 10-16 years experience (cell science experience is preferred) Competencies: GMP experience is required, Regulated industry experience is required Supervision: None
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