Shire Jobs

RESPONSIBILITIES:

• Develop and maintain deep knowledge of specific products and operations related to processes of the SandD 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 SandD equipment per applicable procedures
• Prepare all sanitizing and disinfectant solutions (i.e. LPH, Sporklenz, IPA) to be used in SandD areas
• Clean and sanitize cleanroom areas per the approved/validated schedule
• Record and maintain all use and cleaning activity logs for SandD equipment and cleanrooms
• Collect EM samples as per schedule and deliver theto 3^rd^party testing laboratory for analysis
• Support SandD Supervisor in maintaining supply inventories for the cleanroom areas
• Support SandD Supervisor in performing investigations and assigning corrective actions
• Assist SandD Supervisor in ensuring all procedures are current and reflecting current best practices
• Wear appropriate personal protective equipment (PPE) as recommended by raw material SDSs.
• Other duties as assigned.

QUALIFICATIONS AND JOB SPECIFICATIONS:

• High School diploma, GED, or equivalency required (Associate/Technical/Trade preferred)

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``` - 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 weighing 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).

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``` - Must have a valid drivers 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

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``` - Work requires occasional lifting of up to 35 lbs - Must be able to read at a distance, close to the eyes, and at arms 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 SDSs
• Hazardous conditions may exist, such as proximity to moving mechanical parts, electrical current, and 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.