Quality Specialist

Maintain awareness of, and ensure compliance with, the GxP guidelines and regulations relevant to the services provided. 

Supports and facilitates eQMS activities (i.e., Change Control, Deviations, Quality Events (QEs), CAPAs, Effectiveness Checks, etc.) 

Develop, recommend, and monitor Deviations, QEs and CAPAs. Review, approve, and communicate root cause and CAPAs to stakeholders.  

Perform effectiveness checks on Deviations and QEs to determine efficacy of CAPAs. 

Participate in GxP change management activities including risk and impact analysis review, change plan review and approval, action plan implementation, and tracking to completion, as applicable. 

Support client audits and regulatory inspections processes (including questionnaires): 

Coordinate and finalization of agenda, document provision; ensuring internal logistics and Subject Matter Expert (SME) are in place. 

Coordinate and manage audit CAPA responses including developing responses to CAPAs with support from relevant internal SMEs. 

Track audit and inspection records in eQMS to closure. 

Ensuring audit information is maintained and stored in eQMS. 

Generates and prepares reports to communicate outcomes of quality activities. 

Analyzes and investigates Deviations and QEs to identify areas for improvement in the quality system. 

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

Medical Information specific: 

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

Other duties as needed. 

Fluent in English speaking and writing.  

Knowledge and experience in working with GXP Quality Management Systems. 

Proficient computer skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint). 

Exceptional organization, prioritization, project management and delegation skills; able to multitask. 

Excellent attention to detail and focus on quality. 

Excellent verbal, written, and interpersonal communication skills with the ability to establish strong professional relationships with quality and internal staff, and with clients. 

Exceptional customer service skills within quality and internal staff, and with clients. 

Ability to build positive collaborations with other departments and be open to change.  

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

Flexible and proactive toward changing needs. 

Proactive with the ability to work with minimal supervision. 

University/bachelor's degree and/or appropriate relevant work experience. 

Minimum 2 years of experience working in a Quality Assurance role. 

Deviation, Quality Event, CAPA, Effectiveness Check handling experience preferred. 

Preferred: Knowledge and experience in working with GxP Quality Management Systems including but not limited to record management, reporting, and data analytics. 

Medical Information QA - experience assessing telephone calls in a call center is preferred.