Quality Specialist
Location: United States
Posted: 4 Days Ago
Job Requisition ID: JR 5675
About ProPharma Group
For over 20 years, ProPharma has been supporting the health and wellness of patients by empowering biotech, medical device, and pharmaceutical organizations to advance scientific breakthroughs and bring new therapies to market. As the world’s largest Research Consulting Organization (RCO), ProPharma partners with clients throughout the entire product lifecycle, providing expertise across regulatory sciences, clinical research, pharmacovigilance, and more.
Position Overview
The Quality Specialist will support the delivery of Medical Information, Pharmacovigilance, and/or Clinical services to ensure ongoing compliance with regulatory requirements and industry standards. This role involves continuous monitoring and improvement of quality systems, performing audits, and analyzing data related to quality performance, including CAPAs, deviations, and audits. The Quality Specialist will also support regional and global activities as needed.
Essential Functions
Quality Reporting & Analysis:
Generate and prepare reports to communicate outcomes of quality activities.
Analyze deviations and quality events, identifying areas for system improvement.
Track and trend audit findings and response times.
Corrective and Preventive Actions:
Develop, recommend, and monitor corrective and preventive actions (CAPAs).
Track CAPAs, deviations, and key performance indicators (KPIs) related to quality.
Perform effectiveness checks on CAPAs to evaluate their success.
External Audits & Inspections:
Support external client audits and regulatory inspections by creating reports and gathering necessary documents and data.
eQMS Support:
Facilitate activities related to the electronic Quality Management System (eQMS), such as document management, QA reviews, and change control assessments.
Medical Information Specific Duties:
Evaluate telephone skills and case reports to ensure compliance with standards in medical information.
Skills and Experience Required
Knowledge of Regulatory Standards:
Understanding of Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and Good Documentation Practices (GDP).
Analytical and Communication Skills:
Ability to gather, interpret, and analyze data, identifying trends and anomalies.
Strong written and verbal communication skills to provide feedback and identify improvements.
Attention to Detail:
Excellent accuracy and attention to detail to ensure compliance with quality standards.
Proactive and Organized:
Ability to work independently with minimal supervision, managing multiple priorities and ensuring effective documentation maintenance.
Experience:
0–3 years of experience in quality or regulatory roles, ideally within a medical, clinical, or pharmaceutical environment.
Why ProPharma?
ProPharma celebrates diversity and fosters an inclusive environment where employees are encouraged to be their authentic selves. The company supports innovative thinking and collaboration while maintaining a safe space for all employees to thrive.
Interested? Apply now and help ProPharma deliver high-quality services that meet the evolving needs of the healthcare industry!
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Siliguri |Illinois :
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