Specialist Quality Assurance

****Fully Remote EST and PST preferred 8-5 local time******
Pimary 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