Quality Inspector 1st Shift

The Quality Inspector will provide quality-support to the packaging area, to include oversight for adherence to GMPs FDA, and DEA compliance. The Quality Inspector will utilize practices and techniques within the disciplines of Quality Control, Quality Assurance, and Quality Improvement disciplines. Reads and understands written instructions and SOPs. Knows and understands applicable regulatory requirements that impact job performance. Makes sure relevant activities fall within SOP and regulatory requirements to ensure product conformity.

Prioritizes multiple tasks simultaneously completes tasks in timely manner. Reviews Master Batch Record for accuracy prior to packaging run. Checks, verifies, corrects, and approves component and quantities release for production. Checks product lot number information. Reviews inserts and outserts product sample for accuracy. Reviews and approve tray box labels for accuracy. Issues correct labels for production run and quantity. Conducts line verifications.

Conducts product in-process inspections at designated intervals. Performs final QA inspection for finished product release. Verifies Packaging Personnel reconciliation for accuracy on finished product release. Prepares print outer box release stickers when finished product is approved for release into inventory. Inspects Packaging Room Clean Clear status approve its use for next packaging run. Performs Master Batch Record data entry in required spreadsheets.

Receives label inventory review verify information data input. Reconciles label inventory sheets. Ensures required approved forms are available in vestibules for packaging personnel use. Performs quality duties as assigned.

HS Diploma or GED. Working knowledge of measurement instruments. Prior quality assurance or control exp. Knowledge of federal and state regulations. Proficient in MS Office.

1 year exp pharmaceutical manufacturing preferred. Proficient in ISO, FDA and GMP.