Lead and track quality issues within the QMS, support CAPA creation, pull metrics and trend quality indicators, communicate quality summaries internally and to clients, and assist QA leadership as needed.
Summary of Responsibilities:
- Works with internal teams to progress quality issues in QMS.
- Tracks timeliness of cases in QMS.
- Supports teams in creation of CAPAs.
- Maintains strong working knowledge of QMS.
- Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications.
- Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).
Experience (Minimum Required):
- 8 years in regulatory environment (experience in GXP roles).
- Strong understanding of QMS and CAPA process.
- Ability to work well within a team environment.
- Convey key details of quality issues internally.
- Communicate quality issue summary to clients where applicable.
- Knowledge of GCPs/GxPs.
Preferred Qualifications Include:
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Demands/Work Environment:
- Travel may be required.
- Office-Based (Hybrid), as requested by the line manager.
Learn more about our EEO & Accommodations request here.
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