Unither
QC Sampling & Inspection Technician
ROCHESTER, NY, US
Sponsorship not specifiedDetected 82 days ago
GMP
About the role
- Sampling will also include sampling utilities such as purified water, water for injection, and pure steam.
- Analyzes the results of inspection tests to ensure conformity to specifications.
- Identifies and communicates actual and potential problems.
Responsibilities
- Raw Material and Packaging Components Compliance Verified Performs routine sampling of raw materials and packaging components following applicable SOP's and cGMPs.
- Performs utility sampling for purified water, water for injection, and pure steam.
- May support/provide input for investigations and troubleshooting, with supervision.
- Able to gown to aseptic gowning standards Documentation and Inspection/Sampling Environment Maintained to cGMP Standards Performs data entry and fills out paperwork following applicable SOP's and cGMP/GDPs ensuring accuracy.
- The QC Sampling Inspection Technician performs sampling and inspection of incoming drug substances, raw materials, and packaging components while following applicable SOP's and cGMPs.
- This role will also provide sampling incoming inspection support for development projects.
Requirements
- Maintains and stocks supplies required to complete sampling and inspection activities.
- Maintains and updates training records in timeframe required by applicable procedures.
- Monitors and maintain equipment certification/calibration schedules Writes and participates in investigations as required
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