About this role
RESPONSIBILITIES:
• Develop and maintain deep knowledge of specific products and operations related to processes of the S&D cleanrooms under cGMP operations.
• Ensure technicians are properly trained and follow all procedures and regulations for the area.
• Verify, document and transfer all client picked orders into the cleanroom area for weighing
• Weigh and document all Client orders per specific batch documentation
• Label and package all weighed containers for shipment to applicable locations
• Relabel bulk containers and stage for warehouse personnel to move back to inventory locations
• Clean and maintain all S&D equipment per applicable procedures
• Prepare all sanitizing and disinfectant solutions (i.e. LPH, Sporklenz, IPA) to be used in S&D areas
• Clean and sanitize cleanroom areas per approved/validated schedule
• Record and maintain all use and cleaning activity logs for S&D equipment and cleanrooms
• Collect EM samples as per schedule and deliver to 3rd party testing laboratory for analysis
• Support S&D Supervisor in maintain supply inventories for the cleanroom areas
• Support S&D Supervisor in performing investigations and assigning corrective actions
• Assist S&D Supervisor in ensuring all procedures are current and reflecting current best practices
• Wear appropriate personal protective equipment (PPE) as recommended by raw material SDS's.
• Other duties as assigned.
QUALIFICATIONS AND JOB SPECIFICATIONS:
• High School diploma, GED, or equivalency required (Associates/Technical/Trade preferred)
• Ability to use pallet jacks and drum handling equipment.
• Experience in a cGMP compliant cleanroom environment is a plus.
• Adherence to strict gowning guidelines.
• Must be very proficient in basic math calculations (addition, subtraction, multiplication, and division)
• Must be very organized and have good documentation practices
• Must have impeccable work ethics
TECHNICAL EXPERTISE:
• Skillfully navigate through Warehouse and Quality Management Systems
• Basic Microsoft Office skills: Outlook, Excel, PowerPoint
• Experience with weigh scales and EM equipment a plus
• Experience utilizing RF Guns/Scanners is a plus
ADDITIONAL EMPLOYMENT REQUIREMENTS:
• Must be able to successfully pass all preliminary employment requirements (i.e., drug screen and background check).
• Must have a valid driver's license.
PHYSICAL/MENTAL/VISUAL DEMANDS:
• Almost all Work is performed fully gowned and on your feet for prolonged periods of time.
• Wear PPE as required
• Work requires occasional lifting of up to 35 lbs
• Must be able to read at a distance, close to the eyes, and at arm's length with or without correction.
• Correctly identify and record lot and serial numbers.
WORKING CONDITIONS:
• Activities occur both inside an FDA classified Class C/D (ISO 7/8) cleanroom area and a controlled room temperature warehouse.
• LSL provides PPE to ensure employee safety as recommended by raw material SDS's
• Hazardous conditions may exist, such as proximity to moving mechanical parts, electrical current, working in high places.
EQUIPMENT OPERATED:
• Equipment: pallet jacks, drum handlers, safety hoods, weigh scales, EM devices
• Systems: RF scan guns and RF devices
*NO AGENCIES PLEASE*