Cleanroom Coordinator

Key Responsibilities

• Scheduling weekly production based on personnel, qualifications, components, storage requirements, compounding/aseptic capacities
• Recreating schedules when changes need to be made for various reasons (personnel, equipment, inventory, cleanroom status, added batches requested from production planner.)
• Vial wash weekly production schedule for vials (30, 10, 3mL as well as various tray sizes) and stoppers (13mm and 20mm) for WEST and EAST facility
• Working through issues that arise in the events of: Shut downs, Re-runs/rejecting(scrapping) of vials, stoppers in the event of the cleanroom power outage, Early Term batches for various reasons, Component/API issues
• Processing PPOs for Semi finished goods to be used in Finished good PPOs
• Creating Estimating Releasing Starting Picklist Route Card Reporting as finished Ending Entering/Editing PPOs based off production schedule
• Creating Estimating Releasing Picklist Working with QA for batch issuance, rescheduling, cancellations of PPOs Early termination paperwork
• Daily picking/ completing work of components for production batches
• Reviewing components and equipment needed for future production
• Creating transfer orders to and from FSS to support production
• Movements of components back to warehouse upon completion of production
• Avoiding physical transfer of components when needed (in personal vehicle or going to get the van to transfer what is needed.)
• Cycle counting in warehouse
• Creating counting journals necessary or inventory adjustments
• Scraping expired/waste components
• Absorbing data and writing production NOEs and deviations
• Assisting technicians and QA to get corrections of various documentation
• Assisting outside contractors with work orders, entry into cleanroom, wipe-down
• Work with area manager on process improvement projects
• Support/organization during planned and unplanned shut-downs
• Available from home for coordinating support and cleanroom situations
• Absorbing wipe-down when needed

Basic Qualifications

• Certified Pharmacy Technician - More difficult compounding
• Real expert in either Sterile or Nuclear compounding area
• Has obtained internal certificates for all active SOPs
• Highest risk for contamination

What's on Offer?

• Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.
• We work in an open, dynamic environment where your ideas and talents can shine.