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Works with internal teams to progress quality issues in QMS.
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Tracks timeliness of cases in QMS.
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Supports teams in creation of CAPAs.
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Maintains strong working knowledge of QMS.
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Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.
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Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.
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All other duties as needed or assigned.
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A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
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8 years in regulatory environment (experience in GXP roles).
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Strong understanding of QMS and CAPA process.
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Ability to work well within a team environment.
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Convey key details of quality issues internally.
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Communicate quality issue summary to clients where applicable.
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Knowledge of GCPs/GXPs.
Preferred Qualifications Include:
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Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
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Travel may be required.
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Office-Based (Hybrid), as requested by the line manager.
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