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Quality Assurance Specialist
2 months ago
At Avantor, we are committed to attracting, engaging, and hiring the right talent to drive our global performance. Our Operations, Lab Services, Sales, and other teams rely on our talent acquisition initiatives to achieve this goal.
Our Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.
The RoleThe Quality Assurance (QA) Analyst is responsible for contributing to the performance of our Quality Management System (QMS), ensuring compliance to ISO standards/corporate policies and creating a culture of quality across the North America Distribution facilities.
The QA Analyst participates in the preparation and implementation of QA policies and procedures, performs and manages internal audits, assists or leads customer audits and regulatory inspections, resolves process flow issues, and ensures standards and safety regulations are observed.
The QA Analyst must have excellent communication skills to document and perform QA activities, such as creating internal audit reports, managing root cause investigations of internal errors and customer complaints, preparing Corrective and Preventive Action reports (CAPA), communicating directly with customers, creating and administering internal training materials, and collaborating among cross-functional departments.
The QA Analyst is an integral member of the site-based leadership team and will actively represent Quality at different facilities as well as part of the larger America's Quality team.
The focus of the position is to develop, perform, manage, and continuously improve quality assurance-related activities in compliance with ISO and other related standards/guidance.
Requirements- Bachelor's degree in science (Biology, Chemistry, Environmental, etc.) preferred or demonstrable evidence of job-related professional experience and/or strong internal knowledge of Avantor.
- 1-3 years of quality and/or customer-facing experience preferred.
- Experienced or certified internal auditor for ISO 9001 or related standards/guidance/regulations (ex. GxP, IPEC, etc.).
- Project management experience preferred.
- Experience in using quality management/problem-solving principles, tools, and methodologies (ex. 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.
Strong knowledge of distribution, manufacturing, or production operations.
Excellent communication skills (verbal and written); ability to effectively communicate with customers, registrars, and Avantor associates of different levels.
Strong organizational and time management skills, ability to prioritize work.
Ability to document processes and lead consensus for standardization across Avantor network.
How You Will Create an Impact- Root cause investigations related to customers' complaints against quality process failures/nonconformance, issue CAPAs, and ensure they are closed on time, create and issue formal customer responses, and verify CAPAs are properly implemented and effective.
- Prepare, participate, and host Quality Assurance (QA) related activities (e.g., internal audits, continuous improvement activities, internal training, external audits from customers, registrars, regulatory agencies (e.g., FDA, DEA, etc.), and site tours).
- Create, review, and update controlled documents (Standard Operating Procedures (SOPs), Work Instructions, Forms, Training Materials).
- Identify and implement corrections or process improvements that will ensure the health and compliance of our QMS. Including participating in ABS events related to reduction of errors, process improvements, and improved customer experience.
- Support Lead Auditors with various problem-solving principles, tools, and methodologies (e.g., Lean principles, Six Sigma, PDCA, Kaizen, etc.).
- Collect, manage, and maintain quality data/records, prepare routine/special reports, and interpret such information to assess the health of our QMS and make recommendations to management.
- Participate in the ongoing surveillance and recertification activities required to remain ISO Certified.
- This position is customer-facing and often supports our commercial team. It includes, but is not limited to, preparing for and participating in routine customer calls/events (e.g., Quarterly Business Reviews, Quality Summits, Gemba Walks, etc.).
- Attend and participate in departmental and/or corporate events (e.g., Town Halls, Management Review Meetings, etc.) and may serve as the Subject Matter Expert for Quality to support various continuous improvement initiatives, projects, Kaizens, etc.
