Specialist Quality Assurance #26-26885

Duration: 12 months contract

 Job 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

 Top 3 Must Have Skill Sets:        

• Deviation experience
• CAPA experience
• Overall Quality experience
• 3 YOE after graduating

 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

 Basic Qualifications:

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

 Day to Day Responsibilities:      

• Global Deviation/CAPA support.
  
  

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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