Specialist Quality Assurance

Fully Remote EST and PST preferred 8-5 local time Primary Responsibilities: - Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System’s (CQMS) team – Deviation/CAPA functional area and Corporate functions that do not have Quality oversight - Own and/or QA Approve CAPA and Effectiveness Verification (EV) records - Support annual trend verification report - Support deviation proficiency evaluation program - Support system Business Owner responsibilities such as defining user requirements, drafting data integrity assessments, drafting test scripts/protocols for user testing, ALM testing - Own and/or QA Approve Deviation & CAPA process documentation including work instructions, SOPs, and training materials - Coordinate Investigation Advisory Board (IAB) meetings for multisite and CQMS deviations - Provide support/advice to deviation management system (DQMS) users and approve IS tickets for record updates - Review and approve Change Controls (QA Contact role) - Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data) - Anticipate and prevent potential problems - Lead/support continuous improvement projects related to the Deviation/CAPA process - Provide training for Deviation/CAPA Instructor Led Training sessions - Independently develop solutions that are thorough, practical and consistent with functional objectives - Bring critical events or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes - Admin activities may include the following: maintenance of Deviation/CAPA Smartsheets and distribution lists, querying in deviation management system for data collection/analysis, data gathering for metrics Preferred Qualifications: - Experience owning/approving Major and Minor Deviations - Technical knowledge of IS systems and validation from Business Owner perspective for systems that are used to support the Deviation process - Excellent written and verbal communication skills - Strong organizational skills - Experience in AI related projects - Knowledge of industry and business principles - Demonstrated problem solving abilities - Demonstrated project management skills - Contributes to work group/team by ensuring quality of tasks/ services provided by self and others - Provides training and guidance to others - Extends capabilities by working closely with senior staff/ experts within the internal organization