Quality Specialist

Essential Functions

• 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.
• Care for 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.

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.