Packaging Operator

Job Description Position: Packaging Operator III Duration: 12 Months Location: Tampa, FL Job Summary: • Manage production lines to meet the established production schedule in accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Principles (GMPs) while monitoring product to ensure quality standards are maintained. Job Details: • Comply with a l safety regulations and conduct a l activities in a safe, efficient manner. • Apply 5S and cGMPs in a l areas of responsibility. • Operate high-speed equipment for the manual or automated assembly, fi ling, packaging and labeling of pharmaceutical products: ensuring adherence to specifications. • Perform tasks that may be verified by an independent individual; or perform inspection/verifications of work performed by others. • Clean packaging rooms and machinery in accordance with SOPs and cGMPs. • Conduct Set-Ups, in-process actions, data entry, and other computer-related tasks. • Complete batch records accurately and documents production volumes in accordance with SOPs and cGMPs. • Accept or reject products according to acceptability standards determined by cGMPs, customer requirements, and SOPs. • Complete Line Clearances and Change-Overs on production lines in accordance with SOPs and cGMPs. • Conduct in-process inspections and reconcile incoming and completed components and products to ensure accuracy and accountability. • Perform other duties as assigned. • Incumbent has fu l authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be wi ling to take temporary assignments as required. Regulated Responsibilities (including cGMP and EHS): • Incumbent is expected to be fu ly compliant with a l criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA. • Incumbent wi l work to ensure that the company is in compliance with a l environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate. The incumbent must be wi ling to take temporary assignments as required. Education and Experience: Minimum requirements for this position are: Education: High School degree or equivalent with one year of manufacturing experience. Technical experience: One (1) year related work experience, preferably in a high speed production or manufacturing environment. Regulatory experience: Experience working in a GMP regulated environment preferred. Systems experience: Basic user knowledge of Microsoft Office, SAP experience preferred. Aseptic experience: Experience working in an Aseptic Production environment preferred Running through the packaging line Repair packaging equipment off-site Perform other packaging-related duties Perform manual packaging or operate NGK packaging equipment Recognizing safe packaging equipment operating conditions and proper care of packaging equipment Maintain packaging team purchase documentation Develop packaging vendors in conjunction Make minor repairs to packaging equipment Checking quality of product prior to packaging Conduct testing of packaging designs Assemble product components into final packaging Procure bulk and packaging components Forming, packaging and palletizing equipment Ensuring product and packaging meets quality requirements Ensure that the packaging line and the equipment's on packaging line are clean and set Operate necessary packaging equipment used in packaging foam or OPS products Manage packaging development from design to release Source new packaging technologies Provide packaging development detail in packaging programs from concept initiation through commercialization Maintain all equipment associated with packaging performance Maintain the packaging equipment and all associated equipment