QA Lead

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.