Job Title: Quality System Specialist
Salary: $50,000 - $60,000
Job Overview: The Quality System Specialist position is available for an experienced individual to provide assistance to the Associate Director, Quality Systems to ensure the company is in compliance with regulatory requirements and established procedures.
- Performs all manners of document control activities (review, track, maintain, and archive) in accordance with established policies.
- Assist in managing the internal training program and personnel documentation.
- Assist in the evaluation activities of current and potential vendors.
- Support audits of internal systems as needed.
- Participate in external inspections.
- Assists in the gathering, trending and reporting of metrics that measure and communicate quality performance.
- Applies creative and innovative approaches to maintain a high level of effectiveness, efficiency and productivity in Quality Systems operations within assigned area of responsibility.
- Fosters a climate of teamwork to work across the Quality Systems Department, other departments, vendor partners, and Customers to achieve synergy, effectiveness and efficiency.
- Enhances the effectiveness of the department by developing and maintaining automation, procedures, systems and reporting methodologies.
- Performs other related duties as assigned.
Key Skills: Quality Systems, Audits, Vendors, Regulatory, Compliance, Metrics, Suppliers, ICH, GCP, Microsoft, Clinical, SOP's, Healthcare