Sr. Specialist, User Acceptance Testing/Quality Control Analyst - Hybrid

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Responsibilities

• Responsible for developing, executing and coordinating the end-to-end Interactive Voice/Web Response System User Acceptance Testing. 

• Responsible for the quality review of the URS and UAT deliverables

• Develop UAT documentation consisting of: test plans and scripts, pre, post, specification reviewer and binder UAT checklists, and all other required documents

• Main contact for UAT execution and UAT error resolution

• Ability to lead meetings with internal and external stakeholders to present UAT material

• Ability to guide/instruct participants during the execution of User Acceptance Testing (UAT)

• Ability to manage multiple projects/timelines

• Collaborate with both Sponsor external vendors and internal functions to develop scenarios for testing purposes

• Execute UAT test scripts

• Execute Quality Control related activities

• Address and resolve UAT findings with vendor and core teams

• Work within published study/system project timelines and attend meetings as necessary.

• Conform with GMP and GDP practices.

Education:

• Bachelor's degree required in relevant area, e.g., computer science, engineering, sciences.

Work Experience:

• 3 years of relevant experience.

• Prior clinical trials experience preferred.

• Prior (but not required) Interactive Voice/Web Response System (IVRS and IWRS) experience in a clinical supply chain management environment.

Knowledge, Skills, and Abilities:

• Team oriented attitude and willingness to learn and adapt to new and changing processes

• Ability to develop and execute UAT test documentation (test scripts, test plans, etc.) in a GMP environment according to regulations (e.g., 21-CFR Part11)

• Familiarity with the Software Development Life Cycle (SDLC): reviewing requirements, Testing, Documentation, and Deployment.

• Experience with Microsoft Word, Excel, PowerPoint and Outlook

• Good written and verbal communication skills

• Proven ability to multi-task

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If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your …