Overview

The QA Inspector I 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.

·         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.

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

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

·         Support completed batch records scanning and records retention.

·         Provide QA floor support activities including NCMR investigations and knowledge of deviations, CA, etc.

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

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

·         Adhere to all company Quality policies and procedures

Qualifications

·         High School Diploma, GED, or equivalent required with 1 to 3 years of Quality Inspection required

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

·         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

• Regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear.
• Frequently required to sit; reach with hands and arms and stoop, kneel, crouch, or crawl.
• Must regularly lift and /or move up to 25 pounds.
• Specific vision abilities required by this job include peripheral vision and depth perception.

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 $21-28. 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.