Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.
With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
Quality Specialist 1 is responsible for coordinating internal and external study changes across cross functional teams to ensure study and harmonization requirements are met.
Responsible for monitoring vendor notifications and assessing impact to studies.
Partners with senior level staff to determine actions that need to be communicated cross functionally.
Communicates actions to cross functional 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 cross functional dependencies are aligned and validated in accordance to the new methodology.
Responsible for monitoring changes, identifying impacted studies, and communicating changes to cross functional 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.
Bachelors degree or equivalent combination of 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
CVs must be sent in English
2021-04-09 00 : 00 : 00