Quality Management System Site Analyst / QMS Analyst

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.

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.

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.