Job Description

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.

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