Improved processes and efficiency of extrusion manufacturing operations in the synthesis of polymerproducts while keeping good manufacturing and documentation practices and implementing CAPAs.

• Cleaned, prepped, sterilized equipment and product tanks for use in filling operations.• Trained for compliance and adherence to SOPs, and CGMP standards.• Set up and adjusted fill equipment, performed product filtration, manifold purging, weight adjustments, and bulk sterility samples.• Prepped and tested utility, product and disinfectant filters.• Performed accurate documentation of process with batch and manufacturing production records, and data charts.• Assisted in prepping of lyophilizers for filling operations.• Independently operated Auto clave, Bosch vial washer, and Ultra sonic sink.• Perform capping operations of final product with Bausch & Stroebel capper.• Participated in media fills and validation of new process and equipment with mechanics.• Assist engineers in smoke studies analyzing air currents in clean rooms.• Gown qualified new hires as well as trained on aseptic practices.• Performed BCA swabbing and paperwork to release bulk tanks for production in timely manner.• Contract manufacturing.