US - Manufacturing Associate-Jr

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Job description

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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