QA Inspector

Please note that this is a third shift role: 11:00 PM - 7:30 AM, Sunday night - Thursday night

• Perform Quality Assurance tasks including production line clearances, sampling, inspections, and quality attributes testing designed
• Monitor product quality through the performance of required visual testing.

• Perform routine line clearances/in-process inspections on the packaging lines and compounding suites.
• Ensure routine compliance of day to day activities on the compounding and packaging areas; working with operations personnel to achieve compliance.
• Monitor packaging and compounding to ensure that batch documentation requirements and SOPs are being followed.
• Review the required paperwork for accuracy and compliance, both on line and upon completion of the activity.
• Ability to gown to Grade C standards and perform quality inspection inside cleanroom areas.
• Report non-conformances associated with components, in-process materials, finished products, etc. that may be identified at any stage of production or storage.
• Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/resamples to laboratory in a timely fashion to meet production needs.
• Inspect and approve packaging components, manufacturing/packaging rooms, lines and equipment prior to use.
• Sample in-process items and finished products. Perform required inspections and testing of in-process items and finished products.
• Apply disposition stickers to components, in-process materials and finished products.
• Stage label and inserts on production lines, issuing reports and verifying customer and Renaissance part numbers and comparing information to the staging sheet. Return unused labels and inserts or have them destroyed when requested by customer.
• Process and distribute samples to other teams (i.e. Quality Control Laboratory) for evaluation and testing, as required.
• Review records to confirm accuracy, completeness and GMP compliance.
• Ensure all work performed is documented accurately and completely in batch records, forms, logs and other documents.
• Provide training to QA and Operations staff on proper documentation and inspection procedures.
• Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines.
• Ability to work with computer-based systems and equipment.
• Perform other duties and responsibilities as assigned.