Adheres to all cGMP, safety regulations, and understands QA SOP's with minimal supervision.
Responsible for ensuring all In-Process QA checks (across multiple rooms) are performed within compliance and in accordance to the work instructions
Responsible for calculating and performing AQL (Acceptable Quality Level) Inspections.
Responsible for the review of batch records throughout the packaging process for accuracy and compliance. May be responsible for finalizing or performing a final review prior to submitting an error free batch record to Product Release.
Responsible for escalating any issues found during packaging runs. . Responsible for performing the processes of completing and decommissioning serialization work orders
Responsible for compiling a constructive narrative if needed in the batch record.
Responsible for printing applicable deviations and update the documentation as required by the deviation for the batch record.
Responsible for issuing labeling components for packaging work orders.
Assists in performing root cause analysis for discrepancies.
Responsible for the final clean inspection of production runs prior to use
Responsible for auditing the clean log books weekly for documentation compliance.
Responsible for inspecting, releasing/or rejecting assembled repackaging material issued to production.
Responsible for the final clean inspections of production rooms prior to use.
Performs other duties as assigned.
High School Diploma or GED
Quality Assurance experience
Data Entry experience
Resume and interview required
Two years of Quality experience within a manufactory experience