Overview

About Us:Repligen is an ISO 9001:2015 registered company committed to delivering high-quality products and services to our customers. We strive for continuous improvement and excellence in our processes, ensuring compliance with industry standards and regulatory requirements.

Job Summary:We are seeking an experienced Senior Quality Assurance Associate to support and enhance our Quality Management System (QMS). This role is responsible for ensuring compliance with ISO 9001:2015 standards, driving quality improvements, and assisting in audits, document control, and process validation. The ideal candidate will have a strong background in quality assurance, problem-solving, and cross-functional collaboration.

Responsibilities

Key Responsibilities:

• Ensure compliance with ISO 9001:2015 requirements and company quality policies.
• Maintain and improve the Quality Management System (QMS), including document control and process standardization.
• Conduct internal audits, participate in external audits, and assist in audit preparation.
• Investigate and resolve non-conformances, customer complaints, and corrective/preventive actions (CAPAs).
• Analyze quality data and generate reports for management review.
• Provide training and guidance to employees on quality procedures and best practices.
• Collaborate with cross-functional teams to improve product and process quality.
• Assist in supplier quality management, including audits and performance evaluations.
• Support risk management, change control, and continuous improvement initiatives.

Qualifications

Qualifications:

• College degree in Engineering, Quality Management, or a related field (or equivalent experience).
• Minimum of 3 years of experience in quality assurance, preferably in an ISO 9001:2015-certified environment.
• Strong knowledge of QMS principles, auditing, and process improvement methodologies.
• Experience with root cause analysis, CAPA, and problem-solving techniques.
• Proficiency in using quality management software and Microsoft Office Suite.
• Excellent communication, organizational, and analytical skills.
• Certification in ISO 9001:2015 auditing (e.g., Lead Auditor or Internal Auditor) is a plus.

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/salary range for this role, based in the United States of America is $68,000/Yr.-$72,000/Yr. 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.