Project Coordinator
1 week ago
We are seeking an experienced project coordinator for a short-term contract position at Ventura Solutions LLC. This role will focus on providing comprehensive coordination and oversight for a project, ensuring compliance and operational efficiency within a regulated environment.
Responsibilities
- Oversee and manage the scope, planning, and execution of assigned projects to ensure timely completion and adherence to objectives.
- Contribute hands-on to updating Standard Operating Procedures (SOPs) and Quality/Service Contracts, ensuring compliance with industry standards.
- Manage the development and integration of Process Validation (PV) and Test Method Validation (TMV) for external services.
- Prepare and deliver Subject Matter Expert (SME) training sessions to ensure readiness for FDA audits.
- Provide regular updates to management, highlighting project progress, risks, and corrective actions.
- Support FDA audits with expertise and experience in regulatory compliance.
Qualifications
- Bachelor's degree in science or engineering.
- Experience in project management within regulated industries such as medical devices, pharmaceuticals, or biotechnology.
- Knowledge of Process Validation (PV) and Test Method Validation (TMV).
- Proven ability to update SOPs and Quality/Service Contracts effectively.
- Prior experience with FDA audits is strongly preferred.
- Strong organizational, communication, and problem-solving skills.
Location
- San Jose, CA
Employment Type
- 1099
About Salary
The estimated salary for this position is around $85,000 per year, depending on qualifications and experience.
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