Senior Packaging Operator

Position Scope: The Sr. Packaging Operator will perform advanced visual inspection, packaging, sterilization and cartoning operations to meet commercial product demands. The position follows established procedures in the execution of daily activities and uses judgement in resolving basic issues. Specific Tactical Responsibilities: Performs routine cGMP functions associated with manual/automated packaging operations including visual inspection, pouching, labeling, and cartooning Adjust equipment settings for start-up in accordance to Standard Operating Procedures (SOPs) Executes and verifies cGMP documentation, including training records Understands and adheres to SOPs Performs room sanitization activities in to maintain controlled environment conditions Documents work activities in controlled documents according to Good Documentation Practices Executes 5S tasks independently Assists with training personnel on daily tasks Reports procedural deviations and nonconformance to management Completes SAP inventory transactions Maintains current training on all assigned procedures to include read & understood, skills development, and classroom training activities as required Perform other job related duties as assigned Job Complexity: The position works on equipment and assignments where adherence to proper safety and cGMP procedure is required in order to perform work activities. The Sr. Packaging Operator works on assignments that are moderately difficult requiring judgement in resolving issues or making recommendations. Supervisory Responsibilities: None Required Qualifications: High School Diploma, GED or equivalent experience 3+ years or related experience in a regulated environment 2 years of experience operating and troubleshooting complex production equipment Experience with cGMPs and Good Documentation Practices The ability to read, write and verbally communicate in English The ability to work flexible hours to complete work activities Strong computer literacy Desired Experience, Knowledge, and Skills: Experience working in a clean room environment packaging medical devices or drug products Experience performing computerized transactions Experience conducting transactions with enterprise software; SAP considered an asset

Created: 2024-10-19