QA Inspector II - Repligen

The QA Inspector II will report directly to the QA Supervisor or QA Manager.

This role is responsible for the oversight of all daily QA inspection activities, of finished products and sub-assemblies.

·         Performs in-process finished goods and final inspection including visual inspection.

·         Verification of components to engineering records and documentation requirements.

·         Access and interpret engineering drawings, bill of materials, specifications, and purchase orders to determine quality status and support manufacturing.

·         Prepare, print, and verify documentation and labels for quality and manufacturing process.

·         Review manufacturing batch records against applicable quality requirements and document results of inspections.

·         Train new hires.

·         Identify and clearly communicate nonconformances to specified requirements to Management in timely manner.

·         Proficiently use applicable software to accurately document and maintain the QA inspection process.

·         Support completed batch records scanning and records retention.

·         Initiate NCMRs for non-conforming materials and assist in investigations for deviations, CA, etc.

·         Ensure compliance to current SOP’s and Work Instructions and suggest enhancements to procedures.

·         Review Lot History Records (LHR) for release of finished products and sub-assemblies in SAP.

·         Adhere to all company Quality policies and procedures.

·         High School Diploma, GED, or equivalent with 3 to 5 years of Quality Inspection required.

·         Laboratory or manufacturing setting work experience within a controlled Quality environment preferred.

·         Ability to work independently once training has been completed.

·         Ability to communicate with multiple departments.

·         Detail oriented to all aspects of daily activities.

·         Experience with ISO 9001, ISO 13485, 21CFR820 or equivalent QMS standards.

·         Maintain a positive and team-oriented attitude with good organizational skills.

·         Good written and verbal communication skills.

·         Knowledge of AQL Inspection Plans