Operator, II
Req ID: J2260963
Job Description
OVERALL RESPONSIBILITIES:
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Processes and packages various medical devices and biomaterials product in a controlled environment room
POSITION DUTIES & RESPONSIBILITIES:
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Performs duties and responsibilities as required per work instructions, training guides and S.O.P. guidelines
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Set-up and operate various production equipment used to grind, weigh, measure, dry, mold, ultrasonic, assemble, laser etch and sterile package biomaterials and other medical devices
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Requires a high level of concentration and attention to detail to ensure that products are properly labeled and packaged
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Performs testing and gowning duties and responsibilities required per process sheets, work instructions and training guides
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Follow all procedures in a controlled environment
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Perform equipment set up and PM’s when necessary
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Keeps accurate and up-to-date batch records and data sheets on batches in-process
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Calibrate balances and weigh raw materials
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Complete Quality Records as they relate to the manufacturing process
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Performs SAP transactions and enters required computer data for each packaged product
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Prints LMD, LPPF and BOM and all required packaging labels and performs label reconciliation
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Maintains manufacturing areas in accordance with operating procedures and Lean philosophy
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Strives to maintain product quality at all times while working towards continuous improvements
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Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
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Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer
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Works in other production areas as needed
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Performs other related duties, as required
EDUCATION & EXPERIENCE REQUIREMENTS:
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High School Diploma (minimum)
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Clean room lab technician experience required. (Measuring of powders and liquids)
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Medical device packaging a plus.
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Computer experience with Windows, Manuscript, JDE and Label Software a plus
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Has the ability to recognize equipment and product problems, and perform basic troubleshooting
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Ability to work as a team and multitask in a controlled environment room to meet production schedule
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Demonstrated experience in compliance, quality, and productivity.
Accessibility Accommodation
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