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. 

Necessary Skills and Abilities: 

• 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.

#LI-JB1

#LI-REMOTE