Quality Specialist

Job Summary: 

The Quality Specialist position supports the delivery of Medical Information, Pharmacovigilance, and/or Clinical services, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance. This position may also support regional and global activities as required. 

Essential Functions: 

• Generate and prepare reports to communicate outcomes of quality activities. 

• Analyze and investigate, Deviations and Quality Events to identify areas for improvement in the quality system. 

• Review, approve, and communicate root cause and corrective action to stakeholders. 

• Develop, recommend, and monitor corrective and preventive actions.  Tracks documentation, as necessary. 

• Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs. 

• Record, track, and trend audit findings and response times. 

• Support external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data. 

• Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs. 

• Supports and facilitates eQMS activities (i.e., Document Management, QA review and approvals, Change Control assessments, etc.) 

• Other duties as needed. 

• Medical Information specific: 

• Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met and maintained 

Necessary Skills and Abilities: 

• Maintain awareness of and ensure compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP). 

• Work in a professional manner with clients, team members and management. 

• Excellent computer skills including Microsoft Word and Excel. 

• Analytical skills to gather and interpret data. Must be able to identify trends and outliers. 

• Excellent written and verbal communication skills in providing feedback and identifying improvements where needed. 

• Ability to prioritize and organize the tracking of data, documentation maintenance and record keeping. 

• Excellent accuracy and attention to detail to ensure all products and services meet standard requirements. 

• Proactive with the ability to work with minimal supervision. 

• 0-3 years of experience