QA Analyst

Avantor - Newark, NJ

Full-time - Entry Level

Newark, NJ

10,001+ employees

Merchant Wholesalers, Nondurable Goods

About the position

At Avantor, the Quality Assurance (QA) Analyst plays a pivotal role in enhancing the performance of our Quality Management System (QMS) and ensuring compliance with ISO standards and corporate policies. This position is integral to fostering a culture of quality across our North America Distribution facilities. The QA Analyst is responsible for the preparation and implementation of QA policies and procedures, conducting and managing internal audits, assisting or leading customer audits and regulatory inspections, and resolving process flow issues. The role requires a strong focus on ensuring that standards and safety regulations are adhered to, which is essential for maintaining the integrity of our operations. The QA Analyst must possess excellent communication skills to effectively document and perform QA activities. This includes creating internal audit reports, managing root cause investigations of internal errors and customer complaints, and preparing Corrective and Preventive Action reports (CAPA). The role also involves direct communication with customers, creating and administering internal training materials, and collaborating with cross-functional departments. As a key member of the site-based leadership team, the QA Analyst actively represents Quality at various facilities and is part of the larger America's Quality team. The primary focus of this position is to develop, perform, manage, and continuously improve quality assurance activities in compliance with ISO and other related standards and guidance. This position reports to the Manager of Distribution Quality (US & Canada) and is primarily remote, with a requirement to be on-site at our Bridgeport, NJ location one day a week. The QA Analyst will engage in various activities that include root cause investigations related to customer complaints, hosting QA-related activities, and preparing for and participating in audits from customers and regulatory agencies. The role also involves creating and updating controlled documents, identifying and implementing process improvements, and supporting lead auditors with problem-solving methodologies. Overall, the QA Analyst is crucial in ensuring the health and compliance of our QMS and enhancing customer experience through quality assurance initiatives.

Responsibilities

• Contribute to the performance of the Quality Management System (QMS) and ensure compliance with ISO standards and corporate policies.
• Participate in the preparation and implementation of QA policies and procedures.
• Perform and manage internal audits and assist or lead customer audits and regulatory inspections.
• Resolve process flow issues and ensure standards and safety regulations are observed.
• Document and perform QA activities, including creating internal audit reports and managing root cause investigations.
• Prepare Corrective and Preventive Action reports (CAPA) and communicate directly with customers.
• Create and administer internal training materials and collaborate with cross-functional departments.
• Participate in ongoing surveillance and recertification activities required to remain ISO Certified.
• Collect, manage, and maintain quality data/records and prepare routine/special reports to assess the health of the QMS.
• Support Lead Auditors with various problem-solving principles, tools, and methodologies.

Requirements

• Bachelor's degree in science (Biology, Chemistry, Environmental, etc.) preferred or demonstrable evidence of job-related professional experience.
• 1-3 years of quality and/or customer-facing experience preferred.
• Experienced or certified internal auditor for ISO9001 or related standards/guidance/regulations (e.g., GxP, IPEC, etc.).
• Project management experience preferred.
• Experience in using quality management/problem-solving principles, tools, and methodologies (e.g., Lean principles, Six Sigma, PDCA, Kaizen, etc.) preferred.
• Knowledge of SAP preferred.
• Proficient computer/Microsoft Office skills.
• Experience with EtQ or similar QMS software preferred.

Nice-to-haves

• Strong knowledge of distribution, manufacturing, or production operations.
• Excellent communication skills (verbal and written) to effectively communicate with customers and associates.
• Strong organizational and time management skills, with the ability to prioritize work.
• Ability to document processes and lead consensus for standardization across the Avantor network.

Benefits

• Diverse, equitable, and inclusive culture that supports career growth and success.
• Opportunities for professional development and learning experiences.
• Participation in a global team of over 14,000 associates.