Job Description:
The Quality GxP Specialist supports the principles and application of quality assurance and regulatory compliance. The Specialist provides support and executes routine tasks related to GxP activities. Ideal candidate will have good experience working with Smartsheet.
Key Duties and Responsibilities:
- Participates in compliance related teams working towards the goal of continuous improvement.
- Provides QA support of change controls, GxP investigations and CAPAs. Responsible for generating performance metrics, trends
- Participates in the development of SOPs, protocols and reports
- Participates in continuous improvements of department processes.
- Participates in inspection readiness and support activities
Knowledge and Skills:
- Knowledge of GxP in a pharmaceutical setting
- Ability to collaborate effectively within a team
- Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects
- Strong attention to detail
- Effective communication skills, both verbal and written.
- Basic experience supporting event investigations, Root Cause Analysis and CAPA
- Experience working with cross-functional teams
- Experience in supporting process improvement initiatives, performing gap analysis and risk communication.
Education and Experience:
- Bachelor's degree in scientific or allied health field (or equivalent degree)
- Typically requires 1-3 years of experience, or the equivalent combination of education and experience
Pay Range:
$30-$35/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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No C2C or Third-Party Vendors