Overview

The Lead QA Inspector 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.

Responsibilities

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

·         Provide written and verbal instruction with limited supervision.

·         Perform, organize, and manage verification of components to engineering records and documentation requirements.

·         Work from and assist others in interpreting 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.

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

·         Initiate NCMRs for non-conforming materials and provide data analysis for investigations.

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

·         Support completed batch records scanning and records retention.

·         Provide support for training programs.

·         Train new hires.

·         Demonstrate leadership and guidance to QA Inspector I and QA Inspector II.

·         Ensure compliance to current SOP’s and Work Instructions and generate reports regularly to support enhancements.

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

·        Adherence to all company Quality policies and procedures.

Qualifications

·         High School Diploma, GED, or equivalent with 2 to 4 years of experience in Quality Inspections required.

·         CQI certification preferred.

·         Solid knowledge and experience in Quality Assurance and ability to act as a resource for colleagues.

·         Ability to work independently and lead QA Inspectors.

·         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.

·         Team oriented with good organization skills.

·         Good written and verbal communication skills.

·         Knowledge of AQL Inspection Plans.

What Repligen Offers

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate range for this role, based in the United States of America is $27-32. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.