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Senior Quality Specialist

hace 1 semana


Buenos Aires, Argentina Q² Solutions A tiempo completo

Job Overview
The Scientist, Global Harmonization is responsible for coordinating internal and external study changes across crossfunctional teams to ensure study and harmonization requirements are met.

Essential Functions
- Responsible for monitoring vendor notifications and assessing impact to studies.
- Partners with senior level staff to determine actions that need to be communicated crossfunctionally.
- Communicates actions to crossfunctional partners and follows up to ensure vendor notification actions have been completed.
- Coordinates with lab partners and vendors to ensure notification actions are harmonized across labs, as applicable.
- Coordinates internal change requests to ensure crossfunctional dependencies are aligned and validated in accordance to the new methodology.
- Responsible for monitoring changes, identifying impacted studies, and communicating changes to crossfunctional partners.
- Partners with senior level staff to draft sponsor communications on behalf of Project Management to ensure appropriate change communications. Distributes final communications to impact Project Managers.
- Contributes to CAPA investigations, deviations, and resolution.
- Responsible for supporting six sigma, quality, and safety initiatives.

**Qualifications**:

- Bachelor's Degree Req Or
- Other equivalent combination of education and experience
- 1 year of experience in a regulated lab environment.
- Sound knowledge of clinical lab testing terminology, processes, and equipment.
- General awareness of the broader clinical trial process.
- Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
- Effective organizational and interpersonal skills.
- Effective communication and presentation skills.
- Capable of handling multiple tasks simultaneously.
- Strong attention to detail and accuracy.
- Ability to establish and maintain effective working relationships with coworkers and managers.