Title : Inspection & Packaging Operator I Location : Manati, PR Responsibilities : Perform the inspection and packaging of all finished goods in accordance to establish procedures and specification according to Good Manufacturing Practices, Safety and Standard Operating Procedures. Responsibility includes the inspection/packaging documentation (electronic and/or manual), and cleaning of area. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Operates automatic and/or semi-automatic inspection equipment following all established cGMPs and Safety regulation maintaining equipment up time and running to reduce downtime to a minimum. Performed manual and semi-automated inspection for liquid and lyophilized products, including syringes. Operates automatic and semi-automatic packaging equipment following all established cGMPs and Safety regulation maintaining equipment up time and running to reduce downtime to a minimum. Performed manual and semi-automated packaging and syringes combination products assembly process, when necessary. Cleans all packaging/assembly/inspection lines according to procedures, as needed Verifies components against the packaging process order. Completes area accurate (error free) documentation required before line star up and during the packaging process, following good documentation practices and delivers it on time. Performs housekeeping and handling of waste according to procedure. Inspects the quality and accuracy of all data printed during the inspection/assembly/packaging processes. Detects discrepancies during the packaging process, performs reworks/re-inspection as required by procedures. Attends to all mandatory training meetings for cGMPs, EHS and company policies. Participates in special projects and during audits and regulatory inspection and assists manufacturing activities in other areas within operations, as required. Requirements : High School Diploma One (1) year of experience within regulated manufacturing industry (pharmaceutical). Knowledge in operating the following inspection/assembling/packaging equipment: Manual inspection booths, Semi-automated inspection equipment (e.g. V-90 Seidenader). Labeler machines for Parenteral products. Cartoner machines. Check weigher and/or scales. Electronic equipment. Vision systems. Manual assembly/packaging lines. Secondary packaging semi-automated equipment. Combination product assembly equipment. Accurate visual inspection (e.g. product and component defects). Knowledgeable in CGMP practices, process area, documentation, safety, EHS and hygiene practices. Good communication and Interpersonal skills. Basic knowledge on computerized system. Good leadership and commitment. Ability to enter data into a computer and perform process transactions. Ability to operate pallet jacks. Bilingual, comprehension of the English language. Flexibility to work irregular hours, rotating shifts, weekends and holidays when necessary. Notes : Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description. This position will require the employee to work with chemical, radiological or biological agents that may be hazardous to health if mishandled (including agents who made potentially affect reproduction or the fetus or nursing infants). Employees will be required to follow all safety procedures and use personal protective clothing/equipment where specified.
