Manufacturing Operator III - Fluid Bed Dryer

Essential Functions: Manufacturing Process A depth of knowledge in fluid bed dryer operations is required to be able to operate and troubleshoot fluid bed dryer operations. Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOP's. Executes written SOP's to ensure the purity of materials involved in the manufacturing process Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOP'sExamines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production Cleans manufacturing equipment and facilities according to established SOPsExecutes machine change-overs from batch to batch Completes a variety of assignments independently based on established procedures Identifies process improvements that drive increased efficiency, throughput and quality Samples batches, including validation batches, for quality testing Executes required in-process product quality checks and documents accurately With Master Clean/Surface Clean certification, releases room to be master and/or surface cleaned Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward DocumentationCompletes documentation associated with manufacturing processes (e.g. batch record and logbooks) with detail and accuracy Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets Verifies the manufacturing process on BPR in an accurate and timely manner Provides status updates and operational challenges on status boards Continuous Improvement Proactively identifies and troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Typically participates in Continuous Improvement projects of a higher scope & complexity Safety and Compliance Carries out processing/manufacturing activities safely, as required, on a daily basis. Follows all safety and compliance procedures and participates in required training Adheres to all cGMP compliance/regulatory mandates and quality requirements. Participates in safety teams, start-up discussions, incident debriefs, etc. Ensures compliance with SOPs, Policies and Procedures as required by Company and regulatory agencies Maintains a clean, organized work area.

Training: Conforms to all training requirements, including company required and machine specific training. May become a certified trainer and provide mentoring and training.

Teamwork and Collaboration: Exhibits teamwork and motivates others to achieve project objectives. Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.

Education & Experience: HS diploma with 5 years' Pharmaceutical Manufacturing Operator experience & certification in assigned area, as required Forklift certification is required for certain jobs.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.