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Room Lead, Packaging - Kansas City Missouri
Company: Disability Solutions Location: Kansas City, Missouri
Posted On: 05/17/2024
Room Lead, Packaging Position Summary:Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Kansas City, MO Clinical Supply Services Room Lead, Packaging supports clinical trial projects through the packaging of clinical trial supplies, ensuring work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs).The CSS Room Lead, Packaging is key to ensuring the quality of outputs, adherence to the-- production-- schedule,-- and-- delegation-- of-- job-specific-- tasks.-- This position-- oversees-- the-- execution-- of-- all-- clinical-- and commercial batch records in primary, secondary and the potent packaging areas.This position reports to the Production Supervisor but will also receive instruction from the CSS Team Lead.First Shift: 6:30am - 3:00pm--The Role: - Will lead assigned team members and work alongside them to successfully complete clinical trial and commercial packaging jobs on a daily basis; Responsible for the safety, quality, delivery and cost (SQDC) of all clinical and commercial outputs
- Perform Gemba walks
- Ensure that all employee batch records are reviewed, corrected, and submitted timely
- Alert management of any potential deviations or infractions in a timely manner
- Ensure that the production room is set up to ensure efficiently produced, high-quality outputs
- Adhere to cGMP and GDP when completing and reviewing production batch records
- Will implement and enforce 5S principles with guidance from Team Leads,
- Understands and enforces GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites)
- Other duties as assignedThe Candidate:
- High School degree or equivalent, required
- 2+ years of clinical trial packaging experience or related manufacturing/operations experience preferred
- Highly active containment area (Potent Drug Facility) (respirator fit testing and pulmonary physical required)
- Must be available to work occasional overtime
- 20/20 corrected vision
- Able to distinguish all colors
- Position requires ability to spend extended periods of time in the following GMP environments:
- Controlled Room Temperature 68 degrees F - 77 degrees F (15 degrees C - 25 degrees C)
- Refrigerator 35 degrees F - 46 degrees F (2 degrees C - 8 degrees C)
- Freezer -4 degrees F (-20 degrees C)
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-50 poundsWhy You Should Join Catalent:
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