| Location | ROCHESTER, NY |
JOB SUMMARY:
The QC Sampling & Inspection Technician performs sampling and inspection of incoming drug substances, raw materials, and packaging components while following applicable SOPs and cGMPs. Sampling will also include sampling utilities such as purified water, water for injection, and pure steam. This role will also provide sampling & incoming inspection support for development projects.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Raw Material and Packaging Components Compliance Verified
Performs routine sampling of raw materials and packaging components following applicable SOPs and cGMPs.
Performs utility sampling for purified water, water for injection, and pure steam.
Analyzes the results of inspection tests to ensure conformity to specifications.
Maintains and stocks supplies required to complete sampling and inspection activities.
Identifies and communicates actual and potential problems. May support/provide input for investigations and troubleshooting, with supervision.
Writes basic investigations with some assistance.
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 SOPs and cGMP/GDPs ensuring accuracy.
Reviews colleagues work for accuracy in accordance with SOPs and cGMP/GDP requirements.
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