Sr. Quality Engineer

Overview

Make a global impact-join Repligen.We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us!

We are seeking a Senior Quality Engineer to join our growing Quality team. You will play a key role in oversight of validation activities, management of changes, and investigations/root cause analysis. This is an opportunity to work on cutting-edge projects in a collaborative environment.

We are an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.

You will be part of a cross functional team of highly motivated and collaborative colleagues that troubleshoots and solves complex, technical challenges, promotes continuous improvement and builds world class systems/processes. This role will be based in our Rancho Dominguez, CA site and will report to the Sr. Director of Quality.

Responsibilities

• Use/application of investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes.
• Performing FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability concerns.
• Monitoring the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place.
• Preparing quality/inspection plans, procedures and instructions, and product / raw materials specifications.
• Performing testing, validation, equipment qualifications, and data analysis. Make recommendations for changes in equipment, products, or test methods.
• Reviewing manufacturing planning for appropriate quality requirements.
• Preparing appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures documentation contains the necessary criteria and provisions for effective inspection and testing.
• Compiling and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the completion and effectiveness of corrective actions.
• Performing investigations and prepare reports for customer complaints.
• Conducts or participates in ISO audits, internal audits, and Customer audits.
• Preparing and review Quality Technical Agreements and supplier evaluation surveys.
• Supporting process/product improvement projects, product design reviews, products and raw materials non-conformance investigations, review and disposition.
• Performing ISO, GDP, and technical training.
• Interfacing at all organizational levels within the company, customers, and suppliers.
• Acting as direct quality liaison with Engineering, Manufacturing, Marketing and customers.
• May serve as Lab Safety Coordinator in conjunction with the company's Hazard Communication Program.
  
  

Qualifications

• Bachelor's degree in Engineering or Life Science.
• 7 years Quality Engineering and/or Manufacturing Engineering experience.
• Demonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations.
• Knowledge of Investigative / problem solving tools and scientific/technical investigations.
• Experience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data analysis.
• Good interpersonal, verbal communication and writing skills. Able to express thoughts and concepts at both technical and administrative level.
• Demonstrated ability to proficiently review technical and quality requirements, deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.).
  
  

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 salary range for this role, based in the United States of America is $110,000-160,000. 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.

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