[Hiring] Quality Assurance Specialist @Aditi Consulting

Role Description

• 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

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

Requirements

• Top 3 Must Have Skill Sets:
• Deviation experience
• CAPA experience
• Overall Quality experience
• 3 YOE after graduating

Benefits

• Medical, dental, and vision benefits
• Health savings accounts with qualified medical plan enrollment
• 10 paid days off
• 3 days paid bereavement leave
• 401(k) plan participation with employer match
• Life and disability insurance
• Commuter benefits
• Dependent care flexible spending account
• Accident insurance
• Critical illness insurance
• Hospital indemnity insurance
• Accommodations and reimbursement for work travel
• Discretionary performance or recognition bonus
• Sick leave and mobile phone reimbursement provided based on state or local law