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The Senior Specialist in Quality Assurance will implement improvement standards, manage audits, collect metrics data, and facilitate processes.
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Summary of Responsibilities:
- Tracking and Progression of Quality Issue.
- Development and delivery of training (to operational groups).
- Provide advice and guidance on aspects of quality and compliance.
- Provide consultation to the operational team on quality issues workflow.
- Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency.
- Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills].
- Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization.
- Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).
- Experience may be substituted for education.
Experience (Minimum Required):
- 6 years in regulatory environment (experience in GXP roles).
- Experienced GXP auditor.
- Able to influence QA strategy.
- Ability to communicate with groups.
- Knowledge of multiple operational areas.
- Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.
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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