Position Summary:
The Technician I, Operations - Prep supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local Administration. The Technician, Operations, Prep will rely on experience and judgment to plan and accomplish goals.
Job Responsibilities:
- Prepare vials and verify with the batch record. Ensure part number, quantity and expiries match the batch record. Transfer vials from non-classed area into cleanrooms
- Complete Pre- and Post-cleanings for each batch record
- Complete Pre-line and Post-line for each batch record
- Retrieve, prepare, and clean stainless steel pans for washed vials. Daily clean/handle 50-100 stainless pans
- Set up vial washer to specific vial size being processed
- Wash vials (12,500 - 25,000 vials daily)
- Stage washed/prepped vials for loading in Depyrogenation oven
- Load Depyrogenation oven multiple times (2-3 loads/day)
- Complete documentation for each load of vials washed and for loading/unloading of the oven
- Communicate with the inner cleanroom for unloading the Depy
- Participate in weekly cleaning routine of all cleanrooms
- Assemble daily production tags/labels for traceability of finished product
- Prepare components for Autoclave cycles
- Retrieve and prepare/ clean stainless steel autoclave trays
- Complete documentation for each Autoclave load
- Restock gowning materials when required: Cleanroom garb, hairnets, beard covers, shoe cover
- Assist in palletizing finished product
- This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.
- Perform other duties as assigned
Required Skills:
- Must have good hygiene
- Must be able to stand for long periods of time
- Must be able to work in confined spaces
- Must have good communication skills
- Must have basic math skills (addition, subtraction, division)
Education and Experience Requirements:
- High School diploma / or GED equivalent required
EOE, including disability/vets.
|
