Category: Scientific & Clinical
Job ID: 152106
Date Posted: 05/21/2020
Position QA Label Room Inspector
Location Allentown PA
Employment Type Contract to Hire
QA Label Inspector will perform duties related to confirming that document and labels are within compliance specifications for FDA and GMP guidelines
Adherence to and enforcement of GMP compliance, performing Quality inspections (components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes.
The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.
• Responsible to ensure and enforce GMP compliance
• Responsible to ensure the packaging record is being executed by all associates according to the process steps.
• Responsible for documentation, room identification, equipment and components as follows: Documentation:
Ensure packaging record documentation is accurate (lot numbers, expiration dates, items number, equipment asset numbers, equipment calibration dates) and related data are consistent throughout the record; ensure AQL Report is accurate and complete, and error corrections are made according to GDP in a timely manner.
Read and understand process steps within the packaging record to ensure
compliance during the packaging process.
Review packaging record and corresponding documentation for additional requests, memos, deviations, change controls, etc.
Ensure room/equipment cleaning logs have been completed as applicable.
Ensure room identification information matches packaging record.
Review packaging record for accuracy, legibility, traceability and accountability at the end of each shift or lot, whichever is first.