What are the responsibilities and job description for the Junior GCP Auditor (Remote) position at Actalent?
Description: Supports Principal GCP Lead with GCP audits and Inspection Readiness activities. Responsible for the planning and delivery of global GCP audits for both Pharma and Medtech, including mock agency inspections and Quality Management System development.
Essential Functions
- Responsible for developing, performing, and managing (in cooperation with the Principal GCP Lead) all Quality Assurance related activities such as performance of contracted GCP audits including site and vendor audits. In collaboration with the Principal GCP lead performs gap analysis (by assessing client studies, procedures, and programs against global standards), identifies inherent and applied risk, and subsequently supports QMS build for various stakeholders to include sponsor organizations specifically surrounding GCP and GxP activities.
- Leads mock regulatory inspections and remediation actions to assure regulatory compliance.
- In collaboration with the Principal GCP Lead develop standard operating procedures and quality audit tools to support research activities
- Available to travel both US domestic and International
- Ability to control budgets and ensure adherence to project requirements
- To be able to work with Principal GCP Lead in identifying new solutions
- Identify improvements to existing solutions and always work towards operational excellence
Qualifications
- Bachelor's Degree required
- Minimum of ten years of GCP (Good Clinical Practice) experience• Minimum of 2 years auditing experience
- Works willingly and effectively with others in and across the organization to accomplish team goals
- Knowledge and understanding of the fundamental processes of business, their interaction and the impact of external/internal influences on decision making Excellent interpersonal and networking skills.
- Values people’s opinions and encourages knowledge sharing. High level of energy, drive and enthusiasm
- Able to manage complex relationships and juggle priorities
- Excellent client relationship and influencing skills.
Preferred but not essential Qualifications
- Good Laboratory Practice (GLP) experience
- Knowledge in applying GCP to RWE/non-interventional studies
- Prefer CRO experience
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
