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Specialist Quality Assurance #26-26885

Role overview

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
  • Deviation experience
  • CAPA experience
  • Overall Quality experience

Responsibilities

  • Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System’s (CQMS) team
  • Support annual trend verification report
  • Coordinate Investigation Advisory Board (IAB) meetings for multisite and CQMS deviations
  • Provide training for Deviation/CAPA Instructor Led Training sessions

Key facts

Hard skills

Other skills

  • Analytical Skills
  • Problem Solving
  • Organizational Skills
  • Non-Verbal Communication
  • Teamwork

About the company

US Tech Solutions logo

US Tech Solutions

Staffing & Recruiting

USTECH SOLUTIONS is the largest privately owned diversity workforce partner with a global footprint. For 20+ years, we have partnered with leading MSPs and some of the world’s largest enterprises to deliver a flexible workforce. We serve Fortune 500 giants and growing businesses alike, reinventing the role of humans in a digital workforce. ‘Reinventing Human’ is about connecting you with top talent and seamlessly integrating new hires into your programs through our next gen AI powered Talent platforms. As the largest private diversity supplier in the US, we champion inclusion and unlock hidden potential. We work with leading MSPs and are a trusted strategic partner to the world’s top brands. At USTECH SOLUTIONS, we're inverting the talent hiring pyramid by offering a range of solutions from curated talent pools, workforce management services, and IT services resourcing to IC compliance. Our legacy and close affinity to the computing industry has equipped us with the expertise and vision to provision AI platform solutions that help organizations to innovate faster. Considering Statement of Work? Meet US Tech Digital (ustechdigital.com). We're helping businesses achieve digital leadership through our tailored SOW solutions, utilizing market-leading technology products and our proprietary in-house developed platform solutions. Explore our full range of services and solutions by visiting our website: ustechsolutions.com

Company details

Company typeLarge
IndustryStaffing & Recruiting
Company size1001 - 5000

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Job description

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.

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