Specialist Quality Assurance

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: maintenance of Deviation/CAPA Smartsheets and distribution lists, querying in deviation management system for data collection/analysis, data gathering for metrics

Qualifications

Preferred Qualifications & Skills:

• 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

Top 3 Must-Have Skill Sets:

• Deviation experience
• CAPA experience
• Overall Quality experience
• 3 years of experience after graduating

Pay

The typical base pay for this role across the U.S. is $25.00 – $27.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience.

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 (provided based on state or local law)
• Mobile phone reimbursement (provided based on state or local law)