Quality Management System Site Analyst / QMS Analyst

We are seeking a detail-oriented and driven Quality Management System (QMS) Analyst to support the development, maintenance, and continuous improvement of our Quality Management System. This role plays a key part in ensuring compliance with internal procedures, industry regulations (such as FDA 21 CFR Part 210/211 and ISO 9001 guidelines), and best practices. The ideal candidate will have strong analytical skills, and experience supporting audits, CAPAs, deviations, and change controls.

Key Responsibilities:

• Maintain and support the electronic QMS including document control, training, CAPA, deviation, audit, and change control systems.
• Assist with internal and external audits by preparing documentation, tracking findings, and following up on corrective actions.
• Collaborate with cross-functional teams to investigate deviations, support root cause analysis, and track CAPAs to closure.
• Generate quality metrics and dashboards to identify trends, monitor KPIs, and drive continuous improvement.
• Assist in the development and revision of SOPs, work instructions, and training materials related to QMS processes.
• Ensure timely execution of quality system processes and support inspection readiness activities.
• Maintain the tracking and trending of plant quality metrics for routine review and presentation in the Quality Management Review process. Prepare the QMR slide presentation for meeting purposes.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Minimum 2 years of experience in a regulated environment (pharmaceutical, biotech, or medical device).
• Working knowledge of QMS software and quality system elements such as CAPA, deviations, change control, and audit management.
• Familiarity with FDA and ISO 9001.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office; experience with SAP, and eQMS platforms is a plus.

Preferred Experience:

• Experience supporting GMP operations.
• Experience or training in problem solving tools such as 5 Whys, Fishbone, etc. and risk management.
• Demonstrated ability to work in a fast-paced environment with a high degree of accuracy.

Benefits

Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families.Click here to see our benefits.

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