The QA Specialist 1 will be responsible for providing QA Support for the Manufacturing and Production Departments via line clearance inspections and release of room and equipment for use. Monitor and verify GMPs, and SOP processes are being followed.
Assist with Critical component inspection and release
Perform 2nd QA check upon issuance of Manufacturing Directions, Packaging Instructions, and Label Preparation Instruction
Ensure personnel are following cGMPs and SOPs during processes and ensure facility is in a state of compliance
Assist with staging critical components for scheduled lots
Perform periodic production In-process Fill checks and In-Process Carton Inspection checks
Provide PM card reconciliation as second QA check
Complete inventory adjustment forms as necessary
Assist with critical component investigations as required
Perform balance calibration as necessary
All other duties as may be assigned
Education: High School diploma or equivalent
Experience: 1-3yrs of related pharmaceutical manufacturing experience in a QA function preferred.
Specialized knowledge or training: basic knowledge of GMP’s and FDA regulations.
Travel required in this position None