Key Responsibilities:
• Keep sufficient gowning room supply levels to ensure availability as needed, including tracking in system to reflect correct availability which involves collecting, counting and storing of gowns to/from vendors
• Replenish, stock up and distribute clean room supplies into clean room or general manufacturing area and gowning room, in compliance with SOPs. Perform system transactions & documentation generation as required.
• Deliver production materials, components, and/or manufacturing aids to/from warehouse or other production areas. Receive production material from warehouse, sanitize, unpack and transfer them to appropriate containers/trays into cleanroom or directly into cleanroom, in compliance with SOPs’ requirement. Transfer of waste (used needles, emptied IPA/sporklenz bottles) to waste collection points
• Disposal of/replenish chemicals (IPA/Sporklenz) in the clean room or manufacturing area, including moving, including moving waste (emptied IPA/sparkling bottles) to waste collection points
• Check deliveries to ensure accuracy and timeliness
• Other incidental duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing
Education and Experience:
• Secondary Education; no previous related experience required
• Other: With previous GMP, clean room, medical device experience preferred
Additional Skills:
• Basic computer skills, preferred (e.g., RFSMART)
• Ability to read, comprehend and speak English, and good communication skills required
• Must be able to work in a team environment and with minimum supervision by following detailed operating instructions
• Successful completion of ongoing job training of equipment and process operations
• Basic level of understanding of manufacturing procedures
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
